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1.
BMJ Open ; 9(9): e033150, 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31551393

RESUMO

INTRODUCTION: Inflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI. METHODS AND ANALYSIS: Hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy. ETHICS AND DISSEMINATION: We obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021. TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.

2.
Can J Kidney Health Dis ; 6: 2054358119857718, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31367455

RESUMO

Background: While living kidney donation is considered safe in healthy individuals, perioperative complications can occur due to several factors. Objective: We explored associations between the incidence of perioperative complications and donor characteristics, surgical technique, and surgeon's experience in a large contemporary cohort of living kidney donors. Design: Living kidney donors enrolled prospectively in a multicenter cohort study with some data collected retrospectively after enrollment was complete (eg, surgeon characteristics). Setting: Living kidney donor centers in Canada (n = 12) and Australia (n = 5). Patients: Living kidney donors who donated between 2004 and 2014 and the surgeons who performed the living kidney donor nephrectomies. Measurements: Operative and hospital discharge medical notes were collected prospectively, with data on perioperative (intraoperative and postoperative) information abstracted from notes after enrollment was complete. Complications were graded using the Clavien-Dindo system and further classified into minor and major. In 2016, surgeons who performed the nephrectomies were invited to fill an online survey on their training and experience. Methods: Multivariable logistic regression models with generalized estimating equations were used to compare perioperative complication rates between different groups of donors. The effect of surgeon characteristics on the complication rate was explored using a similar approach. Poisson regression was used to test rates of overall perioperative complications between high- and low-volume centers. Results: Of the 1421 living kidney donor candidates, 1042 individuals proceeded with donation, where 134 (13% [95% confidence interval (CI): 11%-15%]) experienced 142 perioperative complications (55 intraoperative; 87 postoperative). The most common intraoperative complication was organ injury and the most common postoperative complication was ileus. No donors died in the perioperative period. Most complications were minor (90% of 142 complications [95% CI: 86%-96%]); however, 12 donors (1% of 1042 [95% CI: 1%-2%]) experienced a major complication. No statistically significant differences were observed between donor groups and the rate of complications. A total of 43 of 48 eligible surgeons (90%) completed the online survey. Perioperative complication rates did not vary significantly by surgeon characteristics or by high- versus low-volume centers. Limitations: Operative and discharge reporting is not standardized and varies among surgeons. It is possible that some complications were missed. The online survey for surgeons was completed retrospectively, was based on self-report, and has not been validated. We had adequate statistical power only to detect large effects for factors associated with a higher risk of perioperative complications. Conclusions: This study confirms the safety of living kidney donation as evidenced by the low rate of major perioperative complications. We did not identify any donor or surgeon characteristics associated with a higher risk of perioperative complications. Trial registrations: NCT00319579: A Prospective Study of Living Kidney Donation (https://clinicaltrials.gov/ct2/show/NCT00319579)NCT00936078: Living Kidney Donor Study (https://clinicaltrials.gov/ct2/show/NCT00936078).

3.
J Am Soc Nephrol ; 30(7): 1294-1304, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31221679

RESUMO

BACKGROUND: Safely reducing red blood cell transfusions can prevent transfusion-related adverse effects, conserve the blood supply, and reduce health care costs. Both anemia and red blood cell transfusion are independently associated with AKI, but observational data are insufficient to determine whether a restrictive approach to transfusion can be used without increasing AKI risk. METHODS: In a prespecified kidney substudy of a randomized noninferiority trial, we compared a restrictive threshold for red blood cell transfusion (transfuse if hemoglobin<7.5 g/dl, intraoperatively and postoperatively) with a liberal threshold (transfuse if hemoglobin<9.5 g/dl in the operating room or intensive care unit, or if hemoglobin<8.5 g/dl on the nonintensive care ward). We studied 4531 patients undergoing cardiac surgery with cardiopulmonary bypass who had a moderate-to-high risk of perioperative death. The substudy's primary outcome was AKI, defined as a postoperative increase in serum creatinine of ≥0.3 mg/dl within 48 hours of surgery, or ≥50% within 7 days of surgery. RESULTS: Patients in the restrictive-threshold group received significantly fewer transfusions than patients in the liberal-threshold group (1.8 versus 2.9 on average, or 38% fewer transfusions in the restricted-threshold group compared with the liberal-threshold group; P<0.001). AKI occurred in 27.7% of patients in the restrictive-threshold group (624 of 2251) and in 27.9% of patients in the liberal-threshold group (636 of 2280). Similarly, among patients with preoperative CKD, AKI occurred in 33.6% of patients in the restrictive-threshold group (258 of 767) and in 32.5% of patients in the liberal-threshold group (252 of 775). CONCLUSIONS: Among patients undergoing cardiac surgery, a restrictive transfusion approach resulted in fewer red blood cell transfusions without increasing the risk of AKI.

4.
Transplantation ; 103(6): e164-e171, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31246933

RESUMO

BACKGROUND: Living donors may incur out-of-pocket costs during the donation process. While many jurisdictions have programs to reimburse living kidney donors for expenses, few programs have been evaluated. METHODS: The Program for Reimbursing Expenses of Living Organ Donors was launched in the province of Ontario, Canada in 2008 and reimburses travel, parking, accommodation, meals, and loss of income; each category has a limit and the maximum total reimbursement is $5500 CAD. We conducted a case study to compare donors' incurred costs (out-of-pocket and lost income) with amounts reimbursed by Program for Reimbursing Expenses of Living Organ Donors. Donors with complete or partial cost data from a large prospective cohort study were linked to Ontario's reimbursement program to determine the gap between incurred and reimbursed costs (n = 159). RESULTS: The mean gap between costs incurred and costs reimbursed to the donors was $1313 CAD for out-of-pocket costs and $1802 CAD for lost income, representing a mean reimbursement gap of $3115 CAD. Nondirected donors had the highest mean loss for out-of-pocket costs ($2691 CAD) and kidney paired donors had the highest mean loss for lost income ($4084 CAD). There were no significant differences in the mean gap across exploratory subgroups. CONCLUSIONS: Reimbursement programs minimize some of the financial loss for living kidney donors. Opportunities remain to remove the financial burden of living kidney donors.

5.
Transplantation ; 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30830039

RESUMO

BACKGROUND: Living donors may incur out-of-pocket costs during the donation process. While many jurisdictions have programs to reimburse living kidney donors for expenses, few programs have been evaluated. METHODS: The Program for Reimbursing Expenses of Living Organ Donors (PRELOD) was launched in the province of Ontario, Canada in 2008 and reimburses travel, parking, accommodation, meals, and loss of income; each category has a limit and the maximum total reimbursement is $5,500 CAD. We conducted a case study to compare donors' incurred costs (out-of-pocket and lost income) with amounts reimbursed by PRELOD. Donors with complete or partial cost data from a large prospective cohort study were linked to Ontario's reimbursement program to determine the gap between incurred and reimbursed costs (n=159). RESULTS: The mean gap between costs incurred and costs reimbursed to the donors was $1,313 CAD for out-of-pocket costs and $1,802 CAD for lost income, representing a mean reimbursement gap of $3,115 CAD. Non-directed donors had the highest mean loss for out-of-pocket costs ($2,691) and kidney paired donors had the highest mean loss for lost income ($4,084). There were no significant differences in the mean gap across exploratory subgroups. CONCLUSIONS: Reimbursement programs minimize some of the financial loss for living kidney donors. Opportunities remain to remove the financial burden of living kidney donors.

6.
CMAJ ; 191(9): E247-E256, 2019 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-30833491

RESUMO

BACKGROUND: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 µmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS: Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION: Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388.

7.
J Am Soc Nephrol ; 29(12): 2847-2857, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30404908

RESUMO

BACKGROUND: Approximately 40% of the kidneys for transplant worldwide come from living donors. Despite advantages of living donor transplants, rates have stagnated in recent years. One possible barrier may be costs related to the transplant process that potential willing donors may incur for travel, parking, accommodation, and lost productivity. METHODS: To better understand and quantify the financial costs incurred by living kidney donors, we conducted a prospective cohort study, recruiting 912 living kidney donors from 12 transplant centers across Canada between 2009 and 2014; 821 of them completed all or a portion of the costing survey. We report microcosted total, out-of-pocket, and lost productivity costs (in 2016 Canadian dollars) for living kidney donors from donor evaluation start to 3 months after donation. We examined costs according to (1) the donor's relationship with their recipient, including spousal (donation to a partner), emotionally related nonspousal (friend, step-parent, in law), or genetically related; and (2) donation type (directed, paired kidney, or nondirected). RESULTS: Living kidney donors incurred a median (75th percentile) of $1254 ($2589) in out-of-pocket costs and $0 ($1908) in lost productivity costs. On average, total costs were $2226 higher in spousal compared with emotionally related nonspousal donors (P=0.02) and $1664 higher in directed donors compared with nondirected donors (P<0.001). Total costs (out-of-pocket and lost productivity) exceeded $5500 for 205 (25%) donors. CONCLUSIONS: Our results can be used to inform strategies to minimize the financial burden of living donation, which may help improve the donation experience and increase the number of living donor kidney transplants.


Assuntos
Gastos em Saúde , Transplante de Rim/economia , Doadores Vivos , Obtenção de Tecidos e Órgãos/economia , Adulto , Canadá , Estudos de Coortes , Doação Dirigida de Tecido/economia , Eficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Cônjuges , Inquéritos e Questionários
8.
JAMA ; 319(18): 1870-1879, 2018 05 08.
Artigo em Inglês | MEDLINE | ID: mdl-29801012

RESUMO

Importance: In observational studies, increased water intake is associated with better kidney function. Objective: To determine the effect of coaching to increase water intake on kidney function in adults with chronic kidney disease. Design, Setting, and Participants: The CKD WIT (Chronic Kidney Disease Water Intake Trial) randomized clinical trial was conducted in 9 centers in Ontario, Canada, from 2013 until 2017 (last day of follow-up, May 25, 2017). Patients had stage 3 chronic kidney disease (estimated glomerular filtration rate [eGFR] 30-60 mL/min/1.73 m2 and microalbuminuria or macroalbuminuria) and a 24-hour urine volume of less than 3.0 L. Interventions: Patients in the hydration group (n = 316) were coached to drink more water, and those in the control group (n = 315) were coached to maintain usual intake. Main Outcomes and Measures: The primary outcome was change in kidney function (eGFR from baseline to 12 months). Secondary outcomes included 1-year change in plasma copeptin concentration, creatinine clearance, 24-hour urine albumin, and patient-reported overall quality of health (0 [worst possible] to 10 [best possible]). Results: Of 631 randomized patients (mean age, 65.0 years; men, 63.4%; mean eGFR, 43 mL/min/1.73 m2; median urine albumin, 123 mg/d), 12 died (hydration group [n = 5]; control group [n = 7]). Among 590 survivors with 1-year follow-up measurements (95% of 619), the mean change in 24-hour urine volume was 0.6 L per day higher in the hydration group (95% CI, 0.5 to 0.7; P < .001). The mean change in eGFR was -2.2 mL/min/1.73 m2 in the hydration group and -1.9 mL/min/1.73 m2 in the control group (adjusted between-group difference, -0.3 mL/min/1.73 m2 [95% CI, -1.8 to 1.2; P = .74]). The mean between-group differences (hydration vs control) in secondary outcomes were as follows: plasma copeptin, -2.2 pmol/L (95% CI, -3.9 to -0.5; P = .01); creatinine clearance, 3.6 mL/min/1.73 m2 (95% CI, 0.8 to 6.4; P = .01); urine albumin, 7 mg per day (95% CI, -4 to 51; P = .11); and quality of health, 0.2 points (95% CI, -0.3 to 0.3; P = .22). Conclusions and Relevance: Among adults with chronic kidney disease, coaching to increase water intake compared with coaching to maintain the same water intake did not significantly slow the decline in kidney function after 1 year. However, the study may have been underpowered to detect a clinically important difference. Trial Registration: clinicaltrials.gov Identifier: NCT01766687.


Assuntos
Ingestão de Líquidos , Tutoria , Insuficiência Renal Crônica/terapia , Água/administração & dosagem , Idoso , Progressão da Doença , Feminino , Taxa de Filtração Glomerular , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Concentração Osmolar , Educação de Pacientes como Assunto , Insuficiência Renal Crônica/fisiopatologia , Insuficiência Renal Crônica/urina , Urina/química
9.
Can J Kidney Health Dis ; 5: 2054358117749532, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29326843

RESUMO

Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients: Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 µmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2). Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess outcomes, and outcome assessors will be blinded to the intervention assignment. Results: Substudy results will be reported by the year 2018. Conclusions: This substudy will provide generalizable estimates of the risk of acute kidney injury of a restrictive versus liberal approach to red blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. Trial Registration: www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

10.
Nephrology (Carlton) ; 23(12): 1145-1151, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29215180

RESUMO

AIM: To describe the direct and indirect costs incurred by Australian living kidney donors. METHODS: A total of 55 living kidney donors from three centres in Perth, Australia and one centre in Melbourne, Australia (2010-2014) was studied. Forty-nine donors provided information on expenses incurred during the donor evaluation period and up to 3 months after donation. A micro-costing approach was used to measure and value the units of resources consumed. Expenses were grouped as direct costs (ground and air travel, accommodation, and prescription medications) and indirect costs (lost wages and lost productivity). Costs were standardized to the year 2016 in Australian dollars. RESULTS: The most common direct costs were for ground travel (100%), parking (76%), and post-donation pain medications or antibiotics (73%). The highest direct costs were for air travel (median $1986 [three donors]) and ground travel (median $459 [49 donors]). Donors also reported lost wages (median $9891 [37 donors]). The inability to perform household activities or care for dependants were reported by 32 (65%) and 23 (47%) donors. Total direct costs averaged $1682 per donor (median $806 among 49 donors). Total indirect costs averaged $7249 per donor (median $7273 among 49 donors). Total direct and indirect costs averaged $8932 per donor (median $7963 among 49 donors). CONCLUSION: Many Australian living kidney donors incur substantial costs during the donation process. Our findings inform the continued development of policies and programmes designed to minimize costs incurred by living kidney donors.


Assuntos
Custos de Cuidados de Saúde , Gastos em Saúde , Transplante de Rim/economia , Doadores Vivos , Absenteísmo , Adulto , Idoso , Austrália , Custos de Medicamentos , Eficiência , Feminino , Humanos , Renda , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Estudos Prospectivos , Licença Médica/economia , Fatores de Tempo , Viagem/economia
11.
Can J Kidney Health Dis ; 5: 2054358118813088, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30619615

RESUMO

Background: The progression to end-stage renal disease (ESRD) is the most important complication of chronic kidney disease (CKD). Patients with ESRD require dialysis or transplantation to survive, incur numerous complications, and have high mortality rates. Slowing the progression of CKD is an important goal. Unfortunately, even when current treatments are appropriately applied, patients with CKD still progress to ESRD. Current treatments do not address the inflammation and fibrosis that mediate progression to ESRD, but micro-particle curcumin, a natural health product, has both anti-inflammatory and anti-fibrotic properties and may be an effective treatment for patients with CKD. Objective: Micro-particle curcumin for the treatment of CKD-1 (MPAC-CKD-1) will measure the effect of micro-particle curcumin on 2 important markers of CKD progression: albuminuria and estimated glomerular filtration rate (eGFR). Efficacy in either of these markers will justify a larger, international trial to investigate micro-particle curcumin's ability to lower the risk of ESRD in patients with CKD. Design: MPAC-CKD-1 is a multicenter, double-blind prospective randomized controlled trial. Setting: Four kidney disease clinics in Ontario, Canada (3 in London and 1 in Hamilton). Patients: We will enroll patients with CKD, defined by an eGFR between 15 and 60 mL/min/1.73 m2 and a daily albumin excretion of more than 300 mg (or a random urine sample albumin-to-creatinine ratio more than 30 mg/mmol). Measurements: We will measure changes in the co-primary outcomes of urinary albumin-to-creatinine ratio and eGFR at 3 months and 6 months. We will also measure compliance, safety parameters, and changes in health-related quality of life. Methods: Participants will be randomly assigned to receive micro-particle curcumin 90 mg once daily or matching placebo for 6 months. We will enroll at least 500 patients to exclude clinically meaningful 6-month changes in these 2 co-primary outcomes (16% difference in albuminuria, and a 2.3 mL/min/1.73 m2 between-group difference in the 6-month change in eGFR, at a two-tailed alpha of 0.025, power of 0.80). Results: Patient enrollment began on October 1, 2015, with 414 participants randomized as of July 2018. We expect to report the results in 2020. Limitations: MPAC-CKD-1 is not powered to assess outcomes such as the need for renal replacement therapy or death. Conclusions: MPAC-CKD-1 is a multicenter, double-blind prospective randomized controlled trial designed to test whether micro-particle curcumin reduces albuminuria and slows eGFR decline in patients with albuminuric CKD. MPAC-CKD-1 will also test the feasibility of this intervention and inform the need for a future larger scale trial (MPAC-CKD-2). Trial registration: MPAC-CKD-1 is registered with U.S. National Institutes of Health at clinicaltrials.gov (NCT02369549). Protocol version 2.0, December 6, 2014.

12.
Pediatr Diabetes ; 19(3): 457-463, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29063654

RESUMO

BACKGROUND: Vitamin D (VitD) deficiency is prevalent in adolescents with type 1 diabetes (T1D) and is associated with diabetes-related vascular complications in adulthood. The objective of this clinical trial was to assess VitD treatment on endothelial function (EF) and markers of renal inflammation, in this patient group. METHODS: Adolescents with T1D with suboptimal levels of VitD (<37.5 nmol/L) were treated for 12 to 24 weeks with a VitD analog (VitD3 ) at doses of 1000 or 2000 IU daily. The primary end-point assessed the change in reactive hyperemia index (lnRHI), a measure of EF. Secondary end-points included changes in blood pressure, lipid profile, HbA1c and albumin creatinine ratio (ACR). Urinary cytokine/chemokine inflammatory profile was also assessed in a subset of subjects posttreatment. RESULTS: Two hundred and seventy-one subjects were screened for VitD status and 31 VitD deficient subjects with a mean age of 15.7 ± 1.4 years were enrolled and completed the study. Mean 25-OH-VitD levels significantly increased (33.0 ± 12.8 vs 67.0 ± 23.2 nmol/L, P < .01) with a significant improvement in EF following VitD supplementation (lnRHI 0.58 ± 0.20 vs 0.68 ± 0.21, P = .03). VitD supplementation did not significantly impact systolic blood pressure/diastolic blood pressure (SBP/DBP), lipids, HbA1c and ACR and no adverse effects were seen. Several urinary inflammatory cytokines/chemokines: MCP-3 (P < .01), epidermal growth factor (EGF) (P < .01) tumor necrosis factor ß (TNFß) (P = .01), interleukin-10 (IL-10) (P = .01), also significantly decreased post-VitD-treatment. CONCLUSIONS: Treatment with VitD was associated with an improvement in EF and reduced expression of urinary inflammatory markers in adolescents with T1D. This data is suggestive of an additional benefit of VitD supplementation on early markers of microvascular complications.


Assuntos
Diabetes Mellitus Tipo 1/complicações , Angiopatias Diabéticas/prevenção & controle , Endotélio Vascular/efeitos dos fármacos , Vitamina D/uso terapêutico , Vitaminas/uso terapêutico , Adolescente , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/urina , Angiopatias Diabéticas/etiologia , Nefropatias Diabéticas/prevenção & controle , Nefropatias Diabéticas/urina , Feminino , Humanos , Masculino , Vitamina D/farmacologia , Vitaminas/farmacologia
13.
J Am Soc Nephrol ; 26(10): 2571-7, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25711126

RESUMO

Cardiac troponin T (cTnT), even at low concentrations, is a risk factor for 30-day mortality in patients undergoing noncardiac surgery, but it is uncertain whether that risk is generalizable to patients with poor kidney function. We, therefore, evaluated the relationship between cTnT concentration and kidney function on the outcome of 30-day mortality in a post hoc analysis of a prospective cohort study of patients undergoing noncardiac surgery. cTnT was measured for 3 days after surgery and considered abnormal if the peak was ≥0.02 ng/ml. Of the included 14,037 patients, 267 (1.9%) patients died within 30 days of surgery. The adjusted hazard ratios for death with an abnormal cTnT concentration were 4.37 (95% confidence intervals [95% CI], 3.21 to 6.22), 6.15 (95% CI, 2.95 to 140.9), 6.30 (95% CI, 3.12 to 21.23), 1.33 (95% CI, 0.56 to 4.85), and 1.46 (95% CI, 0.46 to 9.21) for eGFR≥60, 45 to <60, 30 to <45, 15 to <30, and <15 ml/min per 1.73 m(2) or on dialysis, respectively. Compared with patients with eGFR≥60 ml/min per 1.73 m(2), the adjusted hazard ratio was significantly lower for patients with eGFR=15 to <30 ml/min per 1.73 m(2) (interaction P value=0.02). Redefining abnormal cTnT concentration as ≥0.03 ng/ml or a change of ≥0.02 ng/ml did not alter results. Because the risk associated with postoperative cTnT levels may be different for patients with eGFR<30 ml/min per 1.73 m(2), additional research is required to determine how to interpret perioperative cTnT values for patients with low kidney function.


Assuntos
Rim/fisiopatologia , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/mortalidade , Troponina T/sangue , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos
14.
JAMA ; 312(21): 2254-64, 2014 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-25399007

RESUMO

IMPORTANCE: Acute kidney injury, a common complication of surgery, is associated with poor outcomes and high health care costs. Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury; however, these effects are uncertain and each intervention has the potential for harm. OBJECTIVE: To determine whether aspirin compared with placebo, and clonidine compared with placebo, alters the risk of perioperative acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS: A 2 × 2 factorial randomized, blinded, clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013. INTERVENTIONS: Patients were assigned to take aspirin (200 mg) or placebo 2 to 4 hours before surgery and then aspirin (100 mg) or placebo daily up to 30 days after surgery, and were assigned to take oral clonidine (0.2 mg) or placebo 2 to 4 hours before surgery, and then a transdermal clonidine patch (which provided clonidine at 0.2 mg/d) or placebo patch that remained until 72 hours after surgery. MAIN OUTCOMES AND MEASURES: Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0.3 mg/dL or greater (≥26.5 µmol/L) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery. RESULTS: Aspirin (n = 3443) vs placebo (n = 3462) did not alter the risk of acute kidney injury (13.4% vs 12.3%, respectively; adjusted relative risk, 1.10; 95% CI, 0.96-1.25). Clonidine (n = 3453) vs placebo (n = 3452) did not alter the risk of acute kidney injury (13.0% vs 12.7%, respectively; adjusted relative risk, 1.03; 95% CI, 0.90-1.18). Aspirin increased the risk of major bleeding. In a post hoc analysis, major bleeding was associated with a greater risk of subsequent acute kidney injury (23.3% when bleeding was present vs 12.3% when bleeding was absent; adjusted hazard ratio, 2.20; 95% CI, 1.72-2.83). Similarly, clonidine increased the risk of clinically important hypotension. In a post hoc analysis, clinically important hypotension was associated with a greater risk of subsequent acute kidney injury (14.3% when hypotension was present vs 11.8% when hypotension was absent; adjusted hazard ratio, 1.34; 95% CI, 1.14-1.58). CONCLUSIONS AND RELEVANCE: Among patients undergoing major noncardiac surgery, neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01082874.


Assuntos
Lesão Renal Aguda/prevenção & controle , Agonistas de Receptores Adrenérgicos alfa 2/administração & dosagem , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clonidina/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Administração Cutânea , Administração Oral , Agonistas de Receptores Adrenérgicos alfa 2/efeitos adversos , Idoso , Clonidina/efeitos adversos , Creatinina/sangue , Esquema de Medicação , Feminino , Hemorragia/induzido quimicamente , Humanos , Hipotensão/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória , Inibidores da Agregação de Plaquetas/efeitos adversos , Complicações Pós-Operatórias , Risco
15.
Can J Diabetes ; 38(4): 250-5, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25092645

RESUMO

OBJECTIVE: To evaluate habitual physical activity in a cohort of adolescents with type 1 diabetes in relation to similarly aged control subjects. METHODS: A cross-sectional case control study of 54 healthy adolescents and 66 patients with type 1 diabetes, 14 to 18 years of age, was conducted. Subjects were surveyed using the Habitual Activity Estimation Scale, a validated self-report instrument to assess activity levels in teens. Subjects' time was classified into categories ranging from inactive (lying down, resting) to very active (increased heart rate and diaphoresis). Active time, described in relative (%) and absolute hours per day was determined for each individual. Age, sex, weight, height and body mass index were recorded for all participants, and the charts of subjects with type 1 diabetes were reviewed for most recent levels of glycated hemoglobin, low-density lipoproteins, high-density lipoproteins, total cholesterol, triglycerides and blood pressure. A regression analysis was performed to determine factors associated with hours spent being active. RESULTS: Subjects with type 1 diabetes spent similar hours being very active (3.4 hours vs. 3.5 hours, p=0.49) but reported more time being inactive than controls (2.0 hours vs. 1.3 hours, p=0.002). In both groups, female gender was associated with more hours spent being active. Metabolic control as assessed by glycated hemoglobin worsened with activity. In the group with type 1 diabetes, more hours spent being active were associated with lower systolic blood pressure, lower serum triglyceride levels, lower total cholesterol and higher high-density lipoproteins, whereas inactivity correlated with higher low-density lipoproteins and total cholesterol. CONCLUSIONS: Adolescents with type 1 diabetes reported significantly more time being inactive than did healthy controls. In patients with type 1 diabetes, activity was associated with improved cardiovascular risk profile.


Assuntos
Diabetes Mellitus Tipo 1/fisiopatologia , Atividade Motora/fisiologia , Adolescente , Fatores Etários , Índice de Massa Corporal , Estudos de Casos e Controles , Estudos Transversais , Feminino , Humanos , Lipídeos/sangue , Masculino , Autorrelato , Fatores Sexuais , Fatores de Tempo
16.
JAMA ; 311(21): 2191-8, 2014 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-24886787

RESUMO

IMPORTANCE: Most acute kidney injury observed in the hospital is defined by sudden mild or moderate increases in the serum creatinine concentration, which may persist for several days. Such acute kidney injury is associated with lower long-term kidney function. However, it has not been demonstrated that an intervention that reduces the risk of such acute kidney injury better preserves long-term kidney function. OBJECTIVES: To characterize the risk of acute kidney injury with an intervention in a randomized clinical trial and to determine if there is a difference between the 2 treatment groups in kidney function 1 year later. DESIGN, SETTING, AND PARTICIPANTS: The Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY) enrolled 4752 patients undergoing first isolated coronary artery bypass graft (CABG) surgery at 79 sites in 19 countries. Patients were randomized to receive CABG surgery either with a beating-heart technique (off-pump) or with cardiopulmonary bypass (on-pump). From January 2010 to November 2011, 2932 patients (from 63 sites in 16 countries) from CORONARY were enrolled into a kidney function substudy to record serum creatinine concentrations during the postoperative period and at 1 year. The last 1-year serum creatinine concentration was recorded on January 18, 2013. MAIN OUTCOMES AND MEASURES: Acute kidney injury within 30 days of surgery (≥50% increase in serum creatinine concentration from prerandomization concentration) and loss of kidney function at 1 year (≥20% loss in estimated glomerular filtration rate from prerandomization level). RESULTS: Off-pump (n = 1472) vs on-pump (n = 1460) CABG surgery reduced the risk of acute kidney injury (17.5% vs 20.8%, respectively; relative risk, 0.83 [95% CI, 0.72-0.97], P = .01); however, there was no significant difference between the 2 groups in the loss of kidney function at 1 year (17.1% vs 15.3%, respectively; relative risk, 1.10 [95% CI, 0.95-1.29], P = .23). Results were consistent with multiple alternate continuous and categorical definitions of acute kidney injury or kidney function loss, and in the subgroup with baseline chronic kidney disease. CONCLUSIONS AND RELEVANCE: Use of off-pump compared with on-pump CABG surgery reduced the risk of postoperative acute kidney injury, without evidence of better preserved kidney function with off-pump CABG surgery at 1 year. In this setting, an intervention that reduced the risk of mild to moderate acute kidney injury did not alter longer-term kidney function. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00463294.


Assuntos
Lesão Renal Aguda/prevenção & controle , Ponte Cardiopulmonar , Ponte de Artéria Coronária sem Circulação Extracorpórea , Idoso , Creatinina/sangue , Feminino , Taxa de Filtração Glomerular , Humanos , Rim/fisiopatologia , Testes de Função Renal , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica , Fatores de Risco , Resultado do Tratamento
17.
BMJ Open ; 4(3): e004842, 2014 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-24598306

RESUMO

INTRODUCTION: Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided into two intravenous doses of 250 mg each may reduce the risk of postoperative acute kidney injury (AKI). METHODS AND ANALYSIS: With respect to the study schedule, over 7000 substudy eligible patients from 81 centres in 18 countries were randomised in December 2013. The authors will use a logistic regression to estimate the adjusted OR of methylprednisolone versus placebo on the primary outcome of AKI in the 14 days following surgery (a postoperative increase in serum creatinine of ≥50%, or ≥26.5 µmol/L, from the preoperative value). The stage of AKI will also be considered, as will the outcome of AKI in those with and without preoperative chronic kidney disease. After receipt of grant funding, the authors began to record additional perioperative serum creatinine measurements in consecutive patients enrolled at substudy participating centres, and patients were invited to enroll in a 6-month serum creatinine collection. In these trial subpopulations, the authors will consider the outcome of AKI defined in alternate ways, and the outcome of a 6-month change in kidney function from the preoperative value. ETHICS AND DISSEMINATION: The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this SIRS AKI substudy. Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. The additional kidney data collection first began for patients enrolled after 1 March 2012. In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. The results will be reported no later than 2015. CLINICAL TRIAL REGISTRATION: Number NCT00427388.


Assuntos
Lesão Renal Aguda/prevenção & controle , Anti-Inflamatórios/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Ponte Cardiopulmonar/efeitos adversos , Metilprednisolona/uso terapêutico , Biomarcadores/sangue , Canadá , Procedimentos Cirúrgicos Cardíacos/métodos , Protocolos Clínicos , Creatinina/sangue , Humanos , Projetos de Pesquisa , Fatores de Risco
18.
BMJ Open ; 4(2): e004886, 2014 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-24568963

RESUMO

INTRODUCTION: Perioperative Ischaemic Evaluation-2 (POISE-2) is an international 2×2 factorial randomised controlled trial of low-dose aspirin versus placebo and low-dose clonidine versus placebo in patients who undergo non-cardiac surgery. Perioperative aspirin (and possibly clonidine) may reduce the risk of postoperative acute kidney injury (AKI). METHODS AND ANALYSIS: After receipt of grant funding, serial postoperative serum creatinine measurements began to be recorded in consecutive patients enrolled at substudy participating centres. With respect to the study schedule, the last of over 6500 substudy patients from 82 centres in 21 countries were randomised in December 2013. The authors will use logistic regression to estimate the adjusted OR of AKI following surgery (compared with the preoperative serum creatinine value, a postoperative increase ≥26.5 µmol/L in the 2 days following surgery or an increase of ≥50% in the 7 days following surgery) comparing each intervention to placebo, and will report the adjusted relative risk reduction. Alternate definitions of AKI will also be considered, as will the outcome of AKI in subgroups defined by the presence of preoperative chronic kidney disease and preoperative chronic aspirin use. At the time of randomisation, a subpopulation agreed to a single measurement of serum creatinine between 3 and 12 months after surgery, and the authors will examine intervention effects on this outcome. ETHICS AND DISSEMINATION: The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this POISE-2 AKI substudy. Ethics approval was obtained for additional kidney data collection in consecutive patients enrolled at participating centres, which first began for patients enrolled after January 2011. In patients who provided consent, the remaining longer term serum creatinine data will be collected throughout 2014. The results of this study will be reported no later than 2015. CLINICAL TRIAL REGISTRATION NUMBER: NCT01082874.


Assuntos
Lesão Renal Aguda/prevenção & controle , Agonistas de Receptores Adrenérgicos alfa 2/administração & dosagem , Anti-Inflamatórios não Esteroides/administração & dosagem , Aspirina/administração & dosagem , Clonidina/administração & dosagem , Complicações Pós-Operatórias/prevenção & controle , Lesão Renal Aguda/sangue , Creatinina/sangue , Taxa de Filtração Glomerular , Humanos , Cuidados Intraoperatórios , Complicações Pós-Operatórias/sangue , Cuidados Pré-Operatórios , Insuficiência Renal Crônica/complicações , Projetos de Pesquisa
19.
Stat Med ; 32(25): 4380-99, 2013 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-23625873

RESUMO

Thrombocytopenia is a condition characterized by extremely low platelet counts, which puts patients at elevated risk of morbidity and mortality because of bleeding. Trials in transfusion medicine are routinely designed to assess the effect of experimental platelet products on patients' platelet counts. In such trials, patients may receive multiple platelet transfusions over a predefined period of treatment, and a response is available from each such administration. The resulting data comprised multiple responses per patient, and although it is natural to want to use this data in testing for treatment effects, naive analyses of the multiple responses can yield biased estimates of the probability of response and associated treatment effects. These biases arise because only subsets of the patients randomized contribute response data on the second and subsequent administrations of therapy and the balance between treatment groups with respect to potential confounding factors is lost. We discuss the design and analysis issues involved in this setting and make recommendations for the design of future platelet transfusion trials.


Assuntos
Ativação Plaquetária/efeitos dos fármacos , Contagem de Plaquetas , Transfusão de Plaquetas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Trombocitopenia/terapia , Causalidade , Simulação por Computador , Humanos , Modelos Logísticos , Estudos Longitudinais , Probabilidade
20.
J Pediatr ; 162(4): 730-5, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23360562

RESUMO

OBJECTIVE: To evaluate the relationship between the social determinants of health (SDH) and glycemic control in a large pediatric type 1 diabetes (T1D) population. STUDY DESIGN: Deprivation Indices (DI) were used to ascertain population-level measures of socioeconomic status, family structure, and ethnicity in patients with T1D followed at The Hospital for Sick Children August 2010-2011 (n = 854). DI quintile scores were determined for individual patients based on de-identified postal codes, and linked to mean patient A1Cs as a measure of glycemic control. We compared mean A1C between the most and least deprived DI quintiles. Associations were estimated controlling for age and sex, and repeated for insulin pump use. RESULTS: The T1D population evaluated in this study was most concentrated in the least and most deprived quintiles of the Material DI. A1C levels were highest in patients with the greatest degree of deprivation (fifth vs first quintile) on the Material DI (9.2% vs 8.3%, P < .0001), Social DI (9.1% vs 8.3%, P < .0001), and Ethnic Concentration Index (8.9% vs 8.4%, P = .03). These relationships between measures of the SDH and A1C were not evident for patients on insulin pumps. On regression analysis, higher A1C was predicted by older age, female sex, not using pump therapy, and being in the most deprived quintile for Material and Social Deprivation, but not Ethnic Concentration. CONCLUSIONS: Measures of the SDH comprising Material and Social Deprivation were significantly associated with suboptimal glycemic control in our pediatric T1D cohort. Use of insulin pump therapy also predicted A1C and may have a moderating effect on these relationships.


Assuntos
Diabetes Mellitus Tipo 1/fisiopatologia , Diabetes Mellitus Tipo 1/terapia , Adolescente , Adulto , Criança , Estudos de Coortes , Estudos Transversais , Grupos Étnicos , Feminino , Humanos , Insulina/metabolismo , Masculino , Ontário , Pobreza , Análise de Regressão , Classe Social , Apoio Social , Resultado do Tratamento
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