RESUMO
Sofosbuvir/Velpatasvir (SOF/VEL) is a combination drug used for chronic hepatitis C (HCV) infection. However, limited information exists regarding the pharmacokinetics of SOF/VEL and its metabolites in hemodialysis patients. We conducted a prospective investigation of the pharmacokinetic parameters of SOF/VEL after a single dose of SOF/VEL (400/100 mg) on days with and without dialysis in 12 Thai hemodialysis patients with chronic HCV infection, who had been undergoing hemodialysis for a duration of 0.5-20 years. Blood samples were collected before dose (0) and 0.5, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, and 12.0 h after dose. Dialysate samples were also collected before dose (0) and 1.0, 2.0, 3.0, and 4.0 h after dose. Plasma and dialysate samples were quantified for SOF and its metabolite, GS-331007, and VEL concentrations using a fully validated LCMS technique. In addition, a preliminary efficacy study was conducted using the proposed SOF/VEL dose reduction regimen in all patients. No differences in SOF/VEL PK parameters between on- and off-dialysis studies. On the contrary, GS-331007 exhibited a 30% reduction in the area under the plasma concentration-time curve from time 0 to 24 h (AUC0-24h) on dialysis days compared with non-dialysis days (AUC0-24h ratio 0.68 vs. 1.04, respectively). The dialysis clearance of SOF and GS-331007 was 9.35 (8.72-15.11) and 8.89 (8.52-14.07) mL/min, respectively. Subsequently, an alternate-day regimen of SOF/VEL (400/100 mg) was administered for 12 weeks, resulting in an undetectable plasma HCV viral load without side effects. Further clinical studies are warranted to validate the efficacy and safety of our proposed dose reduction regimen.
Assuntos
Antivirais , Carbamatos , Esquema de Medicação , Combinação de Medicamentos , Hepatite C Crônica , Compostos Heterocíclicos de 4 ou mais Anéis , Diálise Renal , Sofosbuvir , Humanos , Sofosbuvir/farmacocinética , Sofosbuvir/administração & dosagem , Carbamatos/farmacocinética , Carbamatos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Feminino , Compostos Heterocíclicos de 4 ou mais Anéis/farmacocinética , Compostos Heterocíclicos de 4 ou mais Anéis/administração & dosagem , Hepatite C Crônica/tratamento farmacológico , Antivirais/farmacocinética , Antivirais/administração & dosagem , Estudos Prospectivos , Idoso , Adulto , Resultado do Tratamento , Hepacivirus/efeitos dos fármacos , Hepacivirus/isolamento & purificação , Benzimidazóis , BenzopiranosRESUMO
BACKGROUND: Citrate dialysate (CD) has been successfully used in conventional hemodialysis and continuous renal replacement therapy; however, no study has compared pre- and post-dilution online hemodiafiltration (oL-HDF). Therefore, we aimed to investigate the efficacy of citrate anticoagulation for oL-HDF and the metabolic changes and quality of life of patients on hemodialysis treated using both modes. METHOD: Eight dialysis patients were treated with CD containing 0.8 mmol of citric acid for 4 weeks in each phase. Visual clotting scores were investigated as the primary endpoints. Adequacy of dialysis, laboratory parameters, and quality of life were measured as secondary objectives. RESULTS: The mean clotting scores in the pre-dilution mode were significantly lower than those in the post-dilution mode and in all phases except the heparin-free phase (p < 0.001 in the baseline phase, p = 0.001 in phase 1, and p = 0.023 in phase 2). The values of Kt/V in both modalities were comparable except during the baseline phase, in which the values of pre-dilution were significantly greater than post-dilution (2.36 ± 0.52/week vs. 1.87 ± 0.33/week;95% CI -0.81 to -0.19, p = 0.002). The patient's quality of life regarding their physical activity level was significantly higher in the post-dilution mode than in the pre-dilution mode at baseline and in phase 1 (p = 0.014 and 0.004 at baseline and in phase 1, respectively). Metabolic changes did not differ between the two modes. CONCLUSION: Citrate dialysate decreased or prevented anticoagulation in both pre- and post-dilution modes of oL-HDF without significant side effects and had comparable adequacy of dialysis.
Assuntos
Hemodiafiltração , Humanos , Diálise Renal , Ácido Cítrico , Soluções para Diálise , Qualidade de Vida , Citratos , Anticoagulantes/uso terapêuticoRESUMO
Pulmonary complications are common after SARS-CoV2- infection. However, data on pulmonary sequelae of COVID-19 after recovery in dialysis patients are limited. We determined the prevalence of abnormal lung function tests and CT findings and investigate the association factors impacting pulmonary dysfunction. This prospective observational cohort study enrolled 100 patients with stage 5 chronic kidney disease (CKD) undergoing dialysis who had recovered from COVID-19 for ≥3 months. Pulmonary function test (PFT) and chest computed tomography (CT) were performed. Demographic data and laboratory results were recorded. The mean patient age was 55.15 ± 12.84 years. Twenty-one patients (21%) had severe COVID-19, requiring mechanical ventilation or oxygen supplementation. Pulmonary function tests revealed a restrictive pattern in 41% (95% confidence interval [CI], 31.73-50.78;) and an obstructive pattern in 7.29% (95% CI, 3.19-13.25) patients. The severe group showed PFT test results similar to the non-severe group, with three patients showing severe obstructive lung disease. The CT scan findings included reticulation (64%), multifocal parenchymal band (43%), ground glass opacities (32%), and bronchiectasis (28%). The median total CT score was 3 (interquartile range, 1-8.5). The CT score and PFT findings showed no association with pulmonary dysfunction extent, except in bronchiectasis. Lung function indices were associated with abnormal CT findings. Abnormal CT findings (bronchiectasis, reticulation, and ground-glass opacities) was associated with higher oxygen requirements than normal CT findings (p = 0.008, bronchiectasis; p = 0.041, reticulation; p = 0.032, ground-glass appearance). Aside from CT findings and CRP levels, no significant lung abnormalities were observed in severe and non-severe patients. Some patients had residual symptoms at follow-up. The findings indicate persistence of both radiological and physiological abnormalities in dialysis patients after COVID-19. However, the prevalence of these abnormalities was comparable to that in the normal population; few patients experienced ongoing symptoms. Follow-up observations and evaluations are warranted. Trial registration. Clinicaltrials.gov Identifier: NCT05348759.
Assuntos
Bronquiectasia , COVID-19 , Insuficiência Renal Crônica , Humanos , Adulto , Pessoa de Meia-Idade , Idoso , COVID-19/complicações , COVID-19/diagnóstico por imagem , Seguimentos , Estudos Prospectivos , RNA Viral , SARS-CoV-2 , Pulmão/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico por imagem , Insuficiência Renal Crônica/terapiaRESUMO
In the current study, we calculated the vaccine volume and amount of dead space in a syringe and needle during ChAdox1-n CoV vaccine administration using the air-filled technique. The aim is to reduce the dead space in syringes and needles in order to administer up to 12 doses per vial. The hypothetical situation uses a vial with a similar size as the ChAdox1-n CoV vial. We used distilled water (6.5 mL) to fill the same volume as five vials of ChAdox1-n CoV. When 0.48 mL of distilled water is drawn according to the number on the side of the barrel, an additional 0.10 mL of air can be used in the dead space of the distilled water in the syringe and needle for 60 doses, which can be divided into an average of 0.5 mL per dose. ChAdox1-n CoV was administered using a 1-mL syringe and 25G needle into 12 doses using this air-filled technique. The volume of the recipient vaccine will increase by 20% and save on the budget for low dead space syringes (LDS).
RESUMO
The severe acute respiratory syndrome 2 (SARS-CoV-2) has spread rapidly worldwide, not only causing significant morbidity and mortality but also dramatically increasing health care spending. To manage this in Thailand, healthcare workers first received two doses of the CoronaVac vaccine followed by a booster vaccine with either BNT162b2 vaccine (Pfizer-BioNTech; PZ) or ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca; AZ). Given that the difference in anti-SARS-CoV-2 levels following vaccination may vary depending on the vaccine and on demographic characteristics, we measured the antibody response after the second CoronaVac dose and after the booster with either the PZ or AZ vaccine. Our results in 473 healthcare workers show that the variation in antibody response to the full CoronaVac dose depends on demographic characteristics such as age, gender, body mass index, and underlying disease. After receiving a booster dose, anti-SARS-CoV-2 levels were significantly higher in participants who received the PZ vaccine than in people who received the AZ vaccine. Overall, however, receiving a booster dose of either the PZ or AZ vaccine promoted strong antibody responses, even in the old and those with obesity or diabetes mellitus. In conclusion, our results support the use of a booster vaccination program after full vaccination with the CoronaVac vaccine. This approach effectively enhances immunity against SARS-CoV-2, especially in clinically vulnerable groups and healthcare workers.
RESUMO
We aimed to evaluate the impact of citrate on hemodynamic responses and secondary outcomes, including the filter life span, metabolic complications, and levels of inflammatory cytokines, in critically ill patients who required CRRT compared with those who underwent the heparin-free method. This prospective, multicenter, open-label randomized trial compared regional citrate anticoagulation (RCA) with a heparin-free protocol in severe acute kidney injury (AKI) patients who received continuous venovenous hemodiafiltration (CVVHDF) in the postdilution mode. We measured hemodynamic changes using the FloTrac Sensor/EV1000™ Clinical Platform at certain time points after starting CRRT (0, 6, 12, 24, 48, and 72 h.). The levels of inflammatory cytokines (IL-1ß, IL-6, IL-8, IL-10 and TNF-É) were measured on days 1 and 3. Forty-one patients were recruited and randomized into the heparin (n = 20) and citrate groups (n = 21). The cardiac performances were not significantly different between the 2 groups at any time point. The inflammatory cytokines declined similarly in both treatment arms. The maximum filter survival time was insignificantly longer in the RCA group than in the heparin-free group (44.64 ± 26.56 h. vs p = 0.693 in citrate and heparin free group). No serious side effects were observed for either treatment arm, even in the group of liver dysfunction patients. RCA did not affect hemodynamic changes during CRRT. Inflammatory cytokines decreased similarly in both treatment arms.The filter life span was longer in the citrate group. RCA is a valid alternative to traditional anticoagulation and results in stable hemodynamic parameters.
Assuntos
Injúria Renal Aguda , Sistema Cardiovascular , Terapia de Substituição Renal Contínua , Trombose , Humanos , Ácido Cítrico , Terapia de Substituição Renal Contínua/efeitos adversos , Anticoagulantes/uso terapêutico , Estado Terminal , Estudos Prospectivos , Heparina/uso terapêutico , Citratos/uso terapêutico , Trombose/complicações , Citocinas , Terapia de Substituição Renal/métodos , Injúria Renal Aguda/terapiaRESUMO
BACKGROUND: Vaccination of patients with chronic kidney disease (CKD) and kidney transplants (KTs) may achieve a less robust immune response. Understanding such immune responses is crucial for guiding current and future vaccine dosing strategies. METHODS: This prospective, observational study estimated the immunogenicity of humoral and cellular responses of two SARS-CoV-2 vaccines in different patient groups with CKD compared with controls. Secondary outcomes included adverse events after vaccination and the incidence of COVID-19 breakthrough infection, including illness severity. RESULTS: In total, 212 patients received ChAdOx1 nCoV-19 (89.62 %) or inactivated vaccines (10.38 %).The antibody response against the S protein was analyzed at T0 (before the first injection), T1 (before the second injection), and T2 (12 weeks after the second injection). Seroconversion occurred in 92.31 % of controls at T2 and in 100 % of patients with CKD, 42.86 % undergoing KT, 80.18 % of hemodialysis (HD), and 0 % of patients undergoing continuous ambulatory peritoneal dialysis (CAPD) at T2 of the ChAdOx1 nCoV-19 vaccine. Neutralizing antibody levels by surrogate virus neutralization test were above the protective level at T2 in each group. The KT group exhibited the lowest neutralizing antibody and T cell response. Blood groups O and vaccine type were associated with good immunological responses. After the first dose, 14 individuals (6.6 out of the total population experienced COVID-19 breakthrough infection. CONCLUSION: Immunity among patients with CKD and HD after vaccination was strong and comparable with that of healthy controls. Our study suggested that a single dose of the vaccine is not efficacious and delays may result in breakthrough infection. Some blood groups and types of vaccine can affect the immune response.
Assuntos
Antígenos de Grupos Sanguíneos , COVID-19 , Transplante de Rim , Insuficiência Renal Crônica , Humanos , Vacinas contra COVID-19 , COVID-19/prevenção & controle , SARS-CoV-2 , ChAdOx1 nCoV-19 , Estudos Prospectivos , Vacinação , Anticorpos Neutralizantes , Insuficiência Renal Crônica/complicações , Formação de Anticorpos , Vacinas de Produtos Inativados , Anticorpos AntiviraisRESUMO
BACKGROUND: Post contrast acute kidney injury (PC-AKI) following coronary procedures is a common cause of renal impairment in hospitalized patients, curcuminoids exert anti-inflammatory and antioxidant actions and have shown positive effects on renal hemodynamic protection The objective of this study was to evaluate the role of curcuminoids in the prevention of PC-AKI in chronic kidney disease (CKD) patients. METHODS: This study was a single-center, prospective, double-blind, randomized, placebo-controlled trial in patients with CKD undergoing elective coronary angiography (CAG) at Vajira Hospital from October 2018 to March 2019. Patients were randomized to receive curcuminoids at 1500 mg per day 3 days before and 2 days after the procedure or placebo. The primary outcome was the development of PC-AKI, and the secondary outcomes were overall acute kidney injury (AKI) incidence within 7 days after CAG, changes in estimated glomerular filtration rate (eGFR), interleukin-6 (IL-6), high sensitivity C-reactive protein (hs-CRP), and other adverse events. RESULTS: Sixty patients were enrolled in this study (30 in the curcuminoid group and 30 in the control group). AKI developed in 5 patients in the control group but not in the curcuminoid group (16.67% vs 0%, Pâ =â .052). that curcuminoids could preserve changes in eGFR compared to the placebo group (-1.5 vs 2.5 mL/min/1.73 m2, P valueâ <.001 within 48 hours and -4 vs 1 mL/min/1.73 m2, P value 0.002 within 7 days). However, the hs-CRP and IL-6 levels did not differ between the groups. No serious adverse events were observed in either of the groups. CONCLUSION: Prophylactic administration of curcuminoids, in addition to standard treatment, reduces the incidence of PC-AKI in patients with CKD undergoing elective CAG.
Assuntos
Injúria Renal Aguda , Insuficiência Renal Crônica , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/prevenção & controle , Antioxidantes , Proteína C-Reativa , Meios de Contraste/efeitos adversos , Diarileptanoides , Taxa de Filtração Glomerular , Humanos , Interleucina-6 , Estudos Prospectivos , Insuficiência Renal Crônica/epidemiologiaRESUMO
BACKGROUND: The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pandemic. Ivermectin is an antiparasitic drug that has shown effectiveness against various agents, including SARS-CoV-2. This study aimed to assess the efficacy of ivermectin treatment compared with the standard of care (SOC) among people with mild to moderate COVID-19 symptoms. METHODS: In this randomized, double-blind, placebo-controlled, single-center, parallel-arm, superiority trial among adult hospitalized patients with mild to moderate COVID-19, 72 patients (mean age 48.57 ± 14.80 years) were randomly assigned to either the ivermectin (n=36) or placebo (n=36) group, along with receiving standard care. We aimed to compare the negativity of reverse transcription polymerase chain reaction (RT-PCR) result at days 7 and 14 of enrolment as the primary outcome. The secondary outcomes were duration of hospitalization, frequency of clinical worsening, survival on day 28, and adverse events. RESULTS: At days 7 and 14, no differences were observed in the proportion of PCR-positive patients (RR 0.97 at day 7 (p=0.759) and 0.95 at day 14 (p=0.813). No significant differences were found between the groups for any of the secondary endpoints, and no adverse events were reported. CONCLUSION: No difference was found in the proportion of PCR-positive cases after treatment with ivermectin compared with standard care among patients with mild to moderate COVID-19 symptoms. However, early symptomatic recovery was observed without side effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT05076253. Registered on 8 October 2021, prospectively.
Assuntos
COVID-19 , SARS-CoV-2 , Adulto , Método Duplo-Cego , Humanos , Ivermectina , Pessoa de Meia-Idade , Pandemias , Resultado do TratamentoRESUMO
Introduction: Volume overload and intradialytic hypotension (IDH) are significant complications that can increase the mortality rate in hemodialysis patients.Bioelectrical impedance analysis (BIA) has been used to estimate the optimum weight in chronic hemodialysis patients to prevent intradialytic hypotension. However, data regarding BIA for evaluating hydration in acute kidney injury patients is scarce. We reported the case series of 9 patients who used BIA in comparison with physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy. Methods: We randomized 9 patients with acute kidney injury (AKI) and volume overload who underwent 45 sessions of acute hemodialysis at Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand between October 2017 and February 2018 to BIA and physician -adjusted group. Volume overload was defined as a BIA value of more than>0.4. In the physician-adjusted group (control), the estimates for physical examination and fluid balance were recorded. The primary outcome was an intradialytic hypotensive episode.The secondary outcome was hemodialysis-related adverse events and other clinical outcomes. This work is fully compliant with CONSORT criteria (detailed in the supplemental file). Result: Among 9 patients (55.6% male, median age 65.56 years),the main underlying diseases were hypertension and diabetes mellitus. The main cause of AKI was sepsis. After randomization of overall of 45 sessions in 9 patients with AKI, the intradialytic hypotension event rate in the BIA group was significantly lower than that in the control group (5 events vs 12 events; Pâ¯=â¯0.042). There were no differences in the rates of hemodialysis-related adverse events and other clinical outcomes between the two groups. Conclusion: The use of bioelectrical impedance analysis-guided ultrafiltration in patients with acute kidney injury requiring renal replacement therapy can help reduce intradialytic hypotension.
RESUMO
BACKGROUND: Acute kidney injury (AKI) that develops during pregnancy results from pregnancy-induced hypertension, hemorrhage, and sepsis, associated with morbidity and mortality in the fetus and mother. This meta-analysis was conducted to evaluate the incidence of pregnancy-related AKI (PR-AKI) and adverse clinical outcomes. METHODS: PubMed and Scopus were systematically searched for studies published between 1980 and 2021. We included cross-sectional, retrospective, and prospective cohort studies that reported the incidence of PR-AKI as well as adverse fetal and maternal clinical outcomes. A random-effects model meta-analysis was performed to generate summary estimates. RESULTS: The meta-analysis included 31 studies (57,529,841 participants). The pooled incidence of PR-AKI was 2.0% (95% confidence interval [CI] 1.0-3.7). Only 49.3% of patients received antenatal care. The most common cause of PR-AKI was preeclampsia (36.6%, 95% CI 29.1-44.7). The proportion of patients requiring hemodialysis was 37.2% (95% CI 26.0-49.9). More than 70% of patients had complete recovery of renal function, while 8.5% (95% CI 4.7-14.8) remained dependent on dialysis. The pooled mortality rate of PR-AKI was 12.7% (95% CI 9.0-17.7). In addition, fetal outcomes were favorable, with an alive birth rate of 70.0% (95% CI 61.2-77.4). However, the rate of abortion and/or stillbirth was approximately 25.4% (95% CI 18.1-34.4), and the rate of intrauterine death was 18.6% (95% CI 12.8-26.2). CONCLUSIONS: Although the incidence of PR-AKI is not high, this condition has a high impact on morbidity and mortality in both fetal and maternal outcomes. Early prevention and treatment from health care professionals are needed in PR-AKI, especially in the form of antenatal care and preeclampsia medication.
Assuntos
Injúria Renal Aguda , Pré-Eclâmpsia , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/terapia , Estudos Transversais , Feminino , Humanos , Incidência , Gravidez , Prognóstico , Estudos Prospectivos , Diálise Renal/efeitos adversos , Estudos Retrospectivos , NatimortoRESUMO
Introduction: Preeclampsia (PE) is an important complication of pregnancy that can lead to chronic kidney disease. Soluble fms-like tyrosine kinase-1 (sFlt-1), placental growth factor (PlGF), the sFlt-1/PlGF ratio and endoglin are biomarkers for the differential diagnosis of PE and other diseases. We aimed to explore the correlation of these biomarkers with long-term renal function, blood pressure and the urine albumin/creatinine ratio (UACR) in PE patients. Methods: 34 patients with PE were enrolled. Blood samples for sFlt-1, PlGF, endoglin and the urine albumin/creatinine ratio (UACR) were collected at the time of PE diagnosis (at 35-40 weeks' gestational age (GA) (87.50% of cases). After delivery, the patients were followed up at three months and one year to assess blood pressure, renal function and the UACR. Results: Thirty-four PE patients were included, and 17 completed the study. The estimated glomerular filtration rate (eGFR) decreased significantly at three months and one year after follow-up (128.20 ± 10.34 to 120.75 ± 10.166 ml/min/1.73 m2 (p = 0.001) at three months and 126.71 ± 9.948 to 114.29 ± 11.274 ml/min/1.73 m2 (p < 0.001) at one year). The endoglin level correlated significantly with the eGFR level during PE, but there was no correlation of any biomarker with eGFR, blood pressure, or the UACR at one year. Conclusion: Women with PE have a reduction of eGFR at three months and one year after the diagnosis of PE. Only endoglin is correlated with eGFR antepartum; however, it is not correlated with long-term renal function, blood pressure or the UACR.
RESUMO
BACKGROUND: ChAdOx1 nCoV-19 (AZD 1222) is the main vaccine planned for general administration in Thailand. This vaccine is stored in multiple-dose vials meant to be administered to 10 recipients with a volume of 0.5 mL for each dose. However, the vaccine vials were overfilled, which allows the administration of more than 10 doses per vial. We have stipulated the preparation and use of ChAdOx1 nCoV-19 vaccine using traditional 21 or 25G needles and planned to investigate the immune responses of participants who were administered the ChAdOx1 nCoV-19 vaccine using this technique. METHODS: We measured anti-SARS-CoV-2 anti-spike RBD IgG and neutralising antibody using a surrogate virus neutralising test (sVNT) among adults aged 18-72 years on average of 8.57 weeks (IQR 6.85-8.93) after the first dose of ChAdOx1 nCoV-19 vaccine. The primary outcome was the antibody level. The secondary outcomes included adverse events, factors affecting antibody levels, and incidence of COVID-19 infection. FINDINGS: In all, 60 participants comprised 25 males and 35 females. The mean age was 53.70 ± 17.48 years. BMI was 23.45 ± 3.69 kg/m2. Tests for the neutralising antibody were positive in 60% of the participants (71.4% among males and 44% among females). The median anti-SARS-CoV-2 QuantiVac (anti-spike IgG) level among male and female samples was 111.83 BAU/mL (IQR 73.48-196.74 BAU/mL) and 159.65 BAU/mL (IQR 100.39-371.81), respectively. The positive QuantiVac value of male and female samples was 88.00% and 98.44%, respectively (p-value = 0.382) .A good correlation was observed between neutralising Ab and anti-spike RBD IgG. CONCLUSION: Patients receiving 12-dose per vial injections of ChAdOx1 nCoV-19 exhibited high levels of immunity without severe side effects. This technique can be adopted to maximise the number of doses per vial while preserving vaccine effectiveness.
Assuntos
COVID-19 , ChAdOx1 nCoV-19 , Adulto , Idoso , Vacinas contra COVID-19 , Feminino , Humanos , Imunização Secundária , Imunogenicidade da Vacina , Masculino , Pessoa de Meia-Idade , SARS-CoV-2 , Eficácia de VacinasRESUMO
INTRODUCTION: Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and have pleiotropic effects on kidney injury, albuminuria, and vascular inflammation, especially in animal models. We evaluated the effects of a potent DPP4 inhibitor (gemigliptin) on these processes among patients with diabetic kidney disease (DKD). METHODS: This study employed a multicenter, prospective, randomized, placebo-controlled design. A total of 201 participants were enrolled and randomly assigned to one of two groups, one received treatment with 50 mg gemigliptin daily along with standard care for diabetes mellitus for 6 months. The changes in the coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (eGFR), vascular calcification level, and tubular renal injury marker expression were evaluated at baseline and 6 months. RESULTS: In total, 182 patients completed the study. Significant reductions in hemoglobin A1C levels were observed in both groups. The changes in the CAC score, CAVI, eGFR, and level of proteinuria over the 6 months of the study did not significantly differ between the gemigliptin and control groups. However, biomarkers of vascular calcification, including serum bone alkaline phosphatase and kidney injury, including urine neutrophil gelatinase-associated lipocalin (NGAL)/Cr and urine liver fatty acid-binding protein (L-FABP)/Cr, were improved significantly in the gemigliptin treatment group compared with the control group. No serious adverse events were observed during the study. CONCLUSION: Our study showed that gemigliptin significantly improved the expression of renal tubular injury biomarkers and vascular calcification levels among patients with DKD; however, gemigliptin did not affect renal function or coronary calcification compared with those observed in the control. A larger study with a longer follow-up is essential to verify these beneficial effects. Clinical Trials. This trial is registered with ClinicalTrials.Gov Identifier NCT04705506.
Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Nefropatias Diabéticas/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Piperidonas/uso terapêutico , Pirimidinas/uso terapêutico , Calcificação Vascular/diagnóstico por imagem , Idoso , Fosfatase Alcalina/metabolismo , Índice Tornozelo-Braço , Doença da Artéria Coronariana/fisiopatologia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/metabolismo , Diabetes Mellitus Tipo 2/fisiopatologia , Nefropatias Diabéticas/etiologia , Nefropatias Diabéticas/metabolismo , Proteínas de Ligação a Ácido Graxo/metabolismo , Feminino , Taxa de Filtração Glomerular , Receptor Celular 1 do Vírus da Hepatite A/metabolismo , Humanos , Lipocalina-2/metabolismo , Masculino , Pessoa de Meia-Idade , Osteopontina/metabolismo , Análise de Onda de Pulso , Espécies Reativas de Oxigênio/metabolismo , Calcificação Vascular/fisiopatologiaRESUMO
Since the innovation of our new half-piece elastometric respirator, this type of filtering facepiece respirator (FFR) has been used widely in Thailand. Decontamination methods including ultraviolet C (UVC) germicidal irradiation and 70% alcohol have been implemented to decontaminate these respirators. We then examined the inactivation potential of different decontamination processes on porcine epidemic diarrhea virus (PEDV) and numerous bacterial strains, most of which were skin-derived. To enable rigorous integrity of the masks after repeated decontamination processes, fit tests by the Bitrex test, tensile strength and elongation at break were also evaluated. Our results showed that UVC irradiation at a dose of 3 J/cm2 can eradicate bacteria after 60 min and viruses after 10 min. No fungi were found on the mask surface before decontamination. The good fit test results, tensile strength and elongation at break were still maintained after multiple cycles of decontamination. No evidence of physical degradation was found by gross visual inspection. Alcohol (70%) is also an easy and effective way to eradicate microorganisms on respirators. As the current pandemic is expected to continue for months to years, the need to supply adequate reserves of personnel protective equipment (PPE) and develop effective PPE reprocessing methods is crucial. Our studies demonstrated that the novel silicone mask can be safely reprocessed and decontaminated for many cycles by UVC irradiation, which will help ameliorate the shortage of important protective devices in the COVID-19 pandemic era.
Assuntos
COVID-19 , Descontaminação/métodos , Dispositivos de Proteção Respiratória , Raios Ultravioleta , Ventiladores Mecânicos , Humanos , Pandemias , SiliconesRESUMO
BACKGROUND: Acute kidney injury (AKI) is a common complication encountered in an intensive care unit (ICU). In 2020, the AKI prediction score was developed specifically for critically ill surgical patients who underwent major non-cardiothoracic surgeries. This study aimed to externally validate the AKI prediction score in terms of performance and clinical utility. METHODS: External validation was carried out in a prospective cohort of patients admitted to the ICU of the Faculty of Medicine Vajira Hospital between September 2014 and September 2015. The endpoint was AKI within seven days following ICU admission. Discriminative ability was based on the area under the receiver operating characteristic curves (AuROC). Calibration and clinical usefulness were evaluated. RESULTS: A total of 201 patients were included in the analysis. AKI occurred in 37 (18.4%) patients. The discriminative ability dropped from good in the derivation cohort, to acceptable in the validation cohort (0.839 (95%CI 0.825-0.852) vs. 0.745 (95%CI 0.652-0.838)). No evidence of lack-of-fit was identified (p = 0.754). The score had potential clinical usefulness across the range of threshold probability from 10 to 50%. CONCLUSIONS: The AKI prediction score showed an acceptable discriminative performance and calibration with potential clinical usefulness for predicting AKI risk in surgical patients who underwent major non-cardiothoracic surgery.
RESUMO
Filter facepiece respirators (FFRs) are critical for preventing the transmission of respiratory tract infection disease, especially the dreadful coronavirus 2 (SARs-CoV-2). The N95 mask is a prototype, high-efficiency protective device that can effectively protect against airborne pathogens of less than 0.3 µm. The N95 mask is tightly fitting and has high filtration capacity. The ongoing COVID-19 pandemic has led to a greater requirement for FFR. This rising demand greatly exceeds current production capabilities and stockpiles, resulting in shortages. To address this, our team has invented a new type of half-piece respirator made from silicone and assembled with HEPA or elastostatic filter. A variety of methods have been used to evaluate this new device, including a qualitative fit test with the Bitrex® test kit and filtration test. The preliminary results showed that the new elastometric respirators pass the fit test. The filtration tests also confirmed the superiority of the new respirator over traditional N95 masks, with a mean performance of protection greater than 95%. For the filters, we used two types: SafeStar, which is a kind of HEPA filter; and CareStar, which is considered an elastostatic filler. CareStar was developed to filter virus and bacteria in the operating room, with a limit duration of use up to 24 h, while the safe star was designed for 72 h use and has the quality equivalent to a HEPA filter. Our study demonstrated superior filtration efficacy of both filters, more than 98% even after 24 h of use. CareStar has significantly more filtration efficacy than a safe star (p < 0.001). In conclusion, the development of our new N99 half-piece respirator should ultimately be applicable to healthcare workers with at least non-inferiority to the previously used N 95 respirators. As a universal masking policy is generally implemented, health care workers who are at risk must be protected with appropriate devices. Currently, the adequate supply of such equipment is not feasible. The advent of the new protective device will help protect healthcare workers and replenish the shortage of N95 respirators during the COVID-19 pandemic.
Assuntos
COVID-19/prevenção & controle , Respiradores N95 , Exposição Ocupacional/prevenção & controle , Adulto , Filtros de Ar , Feminino , Filtração , Pessoal de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , SARS-CoV-2 , Adulto JovemAssuntos
Interleucina-6/sangue , Diálise Peritoneal Ambulatorial Contínua , Pró-Calcitonina/sangue , Insuficiência Renal Crônica/terapia , Fator A de Crescimento do Endotélio Vascular/sangue , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Diálise Peritoneal Ambulatorial Contínua/normas , Diálise Peritoneal Ambulatorial Contínua/estatística & dados numéricosRESUMO
BACKGROUND: Citrate anticoagulation is increasingly favored for preventing extracorporeal circuit clotting during renal replacement therapy. This study tested the effect of citrate compared with acetate on heparin avoidance and other parameters. METHODS: Sixty-one chronic hemodialysis (HD) patients were switched from conventional dialysis fluid (acetate) to citrate dialysis fluid and were treated in 3 phases, each lasting 4 weeks: 50%, 25%, and no heparin. Visual clotting score, erythropoiesis stimulating agent (ESA) dose, and laboratory parameters were measured. RESULTS: Except for 2 episodes of clotting, the same dialyzers were used throughout each citrate phase. The mean visual clotting scores were comparable across study periods. Hemoglobin decreased slightly in phase 2 despite the constant ESA dose. The ionized calcium levels rose after HD in most sessions. No adverse events occurred during citrate dialysis. CONCLUSION: During citrate dialysis in chronic HD patients, heparin can be completely avoided. The electrolyte levels, the adequacy of dialysis, and hemoglobin can be maintained without significant adverse events.
Assuntos
Anemia/etiologia , Anticoagulantes/farmacologia , Coagulação Sanguínea/efeitos dos fármacos , Ácido Cítrico/farmacologia , Soluções para Diálise/efeitos adversos , Diálise Renal/efeitos adversos , Adulto , Anemia/diagnóstico , Anticoagulantes/administração & dosagem , Análise Química do Sangue , Testes de Coagulação Sanguínea , Ácido Cítrico/administração & dosagem , Soluções para Diálise/química , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
AIM: Acute kidney injury (AKI) is one of the most serious complications seen in intensive care units (ICUs). However, its epidemiology, risk factors and clinical outcomes in surgical critically ill patients remains unclear. METHODS: A prospective cohort study was conducted in surgical intensive care unit (ICU) of the university hospital in Bangkok, Thailand. AKI was diagnosed according to the KDIGO 2012 criteria. RESULTS: A total of 189 of the 400 patients enrolled in our study developed AKI (47.3%). The severity was: stage 1 = 29.6% of all AKI (56 cases), stage 2 = 30.7% (58 cases), and stage 3 = 39.7% (75 cases). Risk factors of AKI development included a higher BMI, a greater APACHE-II score, septic shock, use of mechanical ventilation, acute medical complications during surgical admission, and pre-existing chronic kidney disease. After adjustment for covariates, only the most severe stage of AKI (stage 3) was associated with increasing 28-day ICU mortality compared with no AKI stage, HR = 7.75 (95% CI, 1.46-41.20, P = 0.02). CONCLUSION: Acute kidney injury is common and is associated with an increase in mortality in surgical ICU patients. There should be more focus on patients with AKI risk factors to prevent this deleterious event.