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1.
Health Qual Life Outcomes ; 19(1): 214, 2021 Sep 06.
Artículo en Inglés | MEDLINE | ID: mdl-34488787

RESUMEN

BACKGROUND: The Needs Assessment Tool: Progressive Disease-Heart Failure (NAT: PD-HF) is a tool created to assess the needs of people living with heart failure and their informal caregivers to assist delivering care in a more comprehensive way that addresses actual needs that are unmet, and to improve quality of life. In this study, we aimed to (1) Translate the tool into German and culturally adapt it. (2) Assess internal consistency, inter-rater reliability, and test-retest reliability of the German NAT: PD-HF. (3) Evaluate whether and how patients and health care personnel understand the tool and its utility. (4) Assess the tool's face validity, applicability, relevance, and acceptability among health care personnel. METHODS: Single-center validation study. The tool was translated from English into German using a forward-backward translation. To assess internal consistency, we used Cronbach´s alpha. To assess inter-rater reliability and test-retest reliability, we used Cohen´s kappa, and to assess validity we used face validity. RESULTS: The translated tool showed good internal consistency. Raters were in substantial agreement on a majority of the questions, and agreement was almost perfect for all the questions in the test-retest analysis. Face validity was rated high by health care personnel. CONCLUSION: The German NAT: PD-HF is a reliable, valid, and internally consistent tool that is well accepted by both patients and health care personnel. However, it is important to keep in mind that effective use of the tool requires training of health care personnel.


Asunto(s)
Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Evaluación de Necesidades/normas , Calidad de Vida/psicología , Encuestas y Cuestionarios/normas , Anciano , Progresión de la Enfermedad , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Cuidados Paliativos , Atención Dirigida al Paciente , Reproducibilidad de los Resultados , Volumen Sistólico , Traducción
2.
Front Immunol ; 11: 599853, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33324417

RESUMEN

A dysregulated response to systemic inflammation is a common pathophysiological feature of most conditions encountered in the intensive care unit (ICU). Recent evidence indicates that a dysregulated inflammatory response is involved in the pathogenesis of various ICU-related disorders associated with high mortality, including sepsis, acute respiratory distress syndrome, cerebral and myocardial ischemia, and acute kidney injury. Moreover, persistent or non-resolving inflammation may lead to the syndrome of persistent critical illness, characterized by acquired immunosuppression, catabolism and poor long-term functional outcomes. Despite decades of research, management of many disorders in the ICU is mostly supportive, and current therapeutic strategies often do not take into account the heterogeneity of the patient population, underlying chronic conditions, nor the individual state of the immune response. Fatty acid-derived lipid mediators are recognized as key players in the generation and resolution of inflammation, and their signature provides specific information on patients' inflammatory status and immune response. Lipidomics is increasingly recognized as a powerful tool to assess lipid metabolism and the interaction between metabolic changes and the immune system via profiling lipid mediators in clinical studies. Within the concept of precision medicine, understanding and characterizing the individual immune response may allow for better stratification of critically ill patients as well as identification of diagnostic and prognostic biomarkers. In this review, we provide an overview of the role of fatty acid-derived lipid mediators as endogenous regulators of the inflammatory, anti-inflammatory and pro-resolving response and future directions for use of clinical lipidomics to identify lipid mediators as diagnostic and prognostic markers in critical illness.


Asunto(s)
Lesión Renal Aguda , Isquemia Encefálica , Lípidos/inmunología , Isquemia Miocárdica , Medicina de Precisión , Síndrome de Dificultad Respiratoria , Sepsis , Lesión Renal Aguda/inmunología , Lesión Renal Aguda/terapia , Isquemia Encefálica/inmunología , Isquemia Encefálica/terapia , Enfermedad Crítica , Humanos , Isquemia Miocárdica/inmunología , Isquemia Miocárdica/terapia , Síndrome de Dificultad Respiratoria/inmunología , Síndrome de Dificultad Respiratoria/terapia , Sepsis/inmunología , Sepsis/terapia
3.
Eur J Anaesthesiol ; 2020 Nov 11.
Artículo en Inglés | MEDLINE | ID: mdl-33186311

RESUMEN

BACKGROUND: Near-infrared spectroscopy (NIRS) is used routinely to monitor cerebral tissue oxygen saturation (SctO2) during cardiopulmonary bypass (CPB) but is rarely employed outside the operating room. Previous studies indicate that patients are at risk of postoperative cerebral oxygen desaturation after cardiac surgery. OBJECTIVES: We aimed to assess perioperative and postoperative changes in NIRS-derived SctO2 in cardiac surgery patients. DESIGN: Prospective observational study. SETTING: The study was conducted in a tertiary referral university hospital in Australia from December 2017 to December 2018. PATIENTS: We studied 34 adult patients (70.6% men) undergoing cardiac surgery requiring CPB and a reference group of 36 patients undergoing noncardiac surgical procedures under general anaesthesia. MAIN OUTCOME MEASURES: We measured SctO2 at baseline, during and after surgery, and then once daily until hospital discharge, for a maximum of 7 days. We used multivariate linear mixed-effects modelling to adjust for all relevant imbalances between the two groups. RESULTS: In the cardiac surgery group, SctO2 was 63.7% [95% confidence interval (CI), 62.0 to 65.5] at baseline and 61.0% (95% CI, 59.1 to 62.9, P = 0.01) on arrival in the ICU. From day 2 to day 7 after cardiac surgery, SctO2 progressively declined. At hospital discharge, SctO2 was significantly lower than baseline, at 53.5% (95% CI, 51.8 to 55.2, P < 0.001). In the reference group, postoperative SctO2 was not significantly different from baseline. On multivariable analysis, cardiac surgery, peripheral vascular disease and time since the operation were associated with greater cerebral desaturation, whereas higher haemoglobin concentrations were associated with slightly better cerebral oxygenation. CONCLUSION: After cardiac surgery on CPB, but not after noncardiac surgery, most patients experience prolonged cerebral desaturation. Such postoperative desaturation remained unresolved 7 days after surgery. The underlying mechanisms and time to resolution of such cerebral desaturations require further investigation.

4.
Crit Care Resusc ; 22(3): 227-236, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32900329

RESUMEN

OBJECTIVE: The systemic inflammatory response syndrome (SIRS) is a dysregulated response that contributes to critical illness. Adjunctive acetylsalicylic acid (ASA) treatment may offer beneficial effects by increasing the synthesis of specialised proresolving mediators (a subset of polyunsaturated fatty acid-derived lipid mediators). DESIGN: Pilot, feasibility, multicentre, double-blind, randomised, placebo-controlled trial. SETTING: Four interdisciplinary intensive care units (ICUs) in Australia. PARTICIPANTS: Critically ill patients with SIRS. INTERVENTIONS: ASA 100 mg 12-hourly or placebo, administered within 24 hours of ICU admission and continued until ICU day 7, discharge or death, whichever came first. MAIN OUTCOME MEASURES: Interleukin-6 (IL-6) serum concentration at 48 hours after randomisation and, in a prespecified subgroup of patients, serum lipid mediator concentrations measured by mass spectrometry. RESULTS: The trial was discontinued in December 2017 due to slow recruitment and after the inclusion of 48 patients. Compared with placebo, ASA did not decrease IL-6 serum concentration at 48 hours. In the 32 patients with analysis of lipid mediators, low-dose ASA increased the concentration of 15-hydroxyeicosatetraenoic acid, a proresolving precursor of lipoxin A4, and reduced the concentration of the proinflammatory cytochrome P-dependent mediators 17-HETE (hydroxyeicosatetraenoic acid), 18-HETE and 20-HETE. In the eicosapentaenoic acid pathway, ASA significantly increased the concentration of the anti-inflammatory mediators 17,18-DiHETE (dihydroxyeicosatetraenoic acid) and 14,15-DiHETE. CONCLUSIONS: In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators. The ability to measure lipid mediators in clinical samples and to monitor the effect of ASA on their levels unlocks a potential area of biological investigation in critical care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN 12614001165673).


Asunto(s)
Aspirina/administración & dosificación , Enfermedad Crítica , Citocinas/efectos de los fármacos , Metaboloma/efectos de los fármacos , Síndrome de Respuesta Inflamatoria Sistémica/tratamiento farmacológico , Australia , Método Doble Ciego , Estudios de Factibilidad , Humanos , Interleucina-6/sangre , Lípidos , Resultado del Tratamiento
5.
Crit Care ; 24(1): 441, 2020 07 16.
Artículo en Inglés | MEDLINE | ID: mdl-32678054

RESUMEN

BACKGROUND: Septic shock is associated with decreased vasopressor responsiveness. Experimental data suggest that central alpha2-agonists like dexmedetomidine (DEX) increase vasopressor responsiveness and reduce catecholamine requirements in septic shock. However, DEX may also cause hypotension and bradycardia. Thus, it remains unclear whether DEX is hemodynamically safe or helpful in this setting. METHODS: In this post hoc subgroup analysis of the Sedation Practice in Intensive Care Evaluation (SPICE III) trial, an international randomized trial comparing early sedation with dexmedetomidine to usual care in critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland. The primary outcome was vasopressor requirements in the first 48 h after randomization, expressed as noradrenaline equivalent dose (NEq [µg/kg/min] = noradrenaline + adrenaline + vasopressin/0.4). RESULTS: Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites. Eighty-three patients with septic shock were included in this subgroup analysis. Of these, 44 (53%) received DEX and 39 (47%) usual care. Vasopressor requirements in the first 48 h were similar between the two groups. Median NEq dose was 0.03 [0.01, 0.07] µg/kg/min in the DEX group and 0.04 [0.01, 0.16] µg/kg/min in the usual care group (p = 0.17). However, patients in the DEX group had a lower NEq/MAP ratio, indicating lower vasopressor requirements to maintain the target MAP. Moreover, on adjusted multivariable analysis, higher dexmedetomidine dose was associated with a lower NEq/MAP ratio. CONCLUSIONS: In critically ill patients with septic shock, patients in the DEX group received similar vasopressor doses in the first 48 h compared to the usual care group. On multivariable adjusted analysis, dexmedetomidine appeared to be associated with lower vasopressor requirements to maintain the target MAP. TRIAL REGISTRATION: The SPICE III trial was registered at ClinicalTrials.gov ( NCT01728558 ).


Asunto(s)
Dexmedetomidina/efectos adversos , Choque Séptico/tratamiento farmacológico , Vasoconstrictores/administración & dosificación , Anciano , Anciano de 80 o más Años , Sedación Profunda/métodos , Dexmedetomidina/farmacología , Dexmedetomidina/uso terapéutico , Femenino , Humanos , Hipnóticos y Sedantes/efectos adversos , Hipnóticos y Sedantes/farmacología , Hipnóticos y Sedantes/uso terapéutico , Unidades de Cuidados Intensivos/organización & administración , Unidades de Cuidados Intensivos/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Respiración Artificial , Estudios Retrospectivos , Choque Séptico/fisiopatología , Suiza , Vasoconstrictores/uso terapéutico , Victoria
6.
Crit Care Med ; 48(7): e620-e628, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32404636

RESUMEN

OBJECTIVES: The potential harm associated with the use of IV vitamin C has not been systematically assessed. We aimed to review the available evidence on harm related to such treatment. DATA SOURCES: We searched MEDLINE, EMBASE, Cochrane Library, National Institute of Health Clinical Trials Register, and World Health Organization International Clinical Trials Registry Platform. STUDY SELECTION: We included studies in adult population that reported harm related to IV high-dose vitamin C which we defined as greater than or equal to 6 g/d, greater than or equal to 75 mg/kg/d, or greater than or equal to 3 g/m/d. DATA EXTRACTION: Two independent investigators screened records and extracted data. DATA SYNTHESIS: We identified 8,149 reports, of which 650 full text were assessed for eligibility, leaving 74 eligible studies. In these studies, 2,801 participants received high-dose vitamin C at a median (interquartile range) dose of 22.5 g/d (8.25-63.75 g/d), 455 mg/kg/d (260-925 mg/kg/d), or 70 g/m/d (50-90 g/m/d); and 932 or more adverse events were reported. Among nine double-blind randomized controlled trials (2,310 patients), adverse events were reported in three studies with an event rate per patient for high-dose vitamin C identical to placebo group in one study (0.1 [1/10] vs 0.1 [1/10]), numerically lower in one study (0.80 [672/839] vs 0.82 [709/869]), and numerically higher in one study (0.33 [24/73] vs 0.23 [17/74]). Six double-blind randomized controlled trials reported no adverse event in either group. Five cases of oxalate nephropathy, five cases of hypernatremia, three cases of hemolysis in glucose-6-phosphate dehydrogenase deficiency patients, two cases of glucometer error, and one case of kidney stones were also reported overall. CONCLUSIONS: There is no consistent evidence that IV high-dose vitamin C therapy is more harmful than placebo in double-blind randomized controlled trials. However, reports of oxalate nephropathy, hypernatremia, glucometer error, and hemolysis in glucose-6-phosphate dehydrogenase deficiency patients warrant specific monitoring.


Asunto(s)
Ácido Ascórbico/efectos adversos , Vitaminas/efectos adversos , Ácido Ascórbico/administración & dosificación , Ácido Ascórbico/uso terapéutico , Humanos , Vitaminas/administración & dosificación , Vitaminas/uso terapéutico
7.
JAMA ; 323(5): 423-431, 2020 02 04.
Artículo en Inglés | MEDLINE | ID: mdl-31950979

RESUMEN

Importance: It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock. Objective: To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock. Design, Setting, and Participants: Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019. Interventions: Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days. Main Outcomes and Measures: The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality. Results: Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported. Conclusions and Relevance: In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone. Trial Registration: ClinicalTrials.gov Identifier: NCT03333278.


Asunto(s)
Antiinflamatorios/uso terapéutico , Ácido Ascórbico/uso terapéutico , Hidrocortisona/uso terapéutico , Choque Séptico/tratamiento farmacológico , Tiamina/uso terapéutico , Vitaminas/uso terapéutico , Administración Intravenosa , Anciano , Antiinflamatorios/administración & dosificación , Ácido Ascórbico/administración & dosificación , Quimioterapia Combinada , Femenino , Mortalidad Hospitalaria , Humanos , Hidrocortisona/administración & dosificación , Masculino , Persona de Mediana Edad , Choque Séptico/mortalidad , Vasoconstrictores/uso terapéutico , Vitaminas/administración & dosificación
8.
J Crit Care ; 55: 177-183, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31739087

RESUMEN

PURPOSE: To assess the impact of gender and pre-menopausal state on short- and long-term outcomes in patients with septic shock. MATERIAL AND METHODS: Cohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial, an international randomized controlled trial comparing early goal-directed therapy (EGDT) to usual care in patients with early septic shock, conducted between October 2008 and April 2014. The primary exposure in this analysis was legal gender and the secondary exposure was pre-menopausal state defined by chronological age (≤ 50 years). RESULTS: 641 (40.3%) of all 1591 ARISE trial participants in the intention-to-treat population were females and overall, 337 (21.2%) (146 females) patients were 50  years of age or younger. After risk-adjustment, we could not identify any survival benefit for female patients at day 90 in the younger (≤50 years) (adjusted Odds Ratio (aOR): 0.91 (0.46-1.89), p = .85) nor in the older (>50 years) age-group (aOR: 1.10 (0.81-1.49), p = .56). Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures. CONCLUSIONS: This post-hoc analysis of a large multi-center trial in early septic shock has shown no short- or long-term survival effect for women overall as well as in the pre-menopausal age-group.


Asunto(s)
Calidad de Vida , Factores Sexuales , Choque Séptico/mortalidad , Choque Séptico/psicología , Adulto , Anciano , Tratamiento Precoz Dirigido por Objetivos , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Premenopausia , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Resucitación/mortalidad , Resultado del Tratamiento
9.
BMJ Open ; 9(11): e033458, 2019 11 12.
Artículo en Inglés | MEDLINE | ID: mdl-31722954

RESUMEN

INTRODUCTION: Vasoplegia is common and associated with a poor prognosis in patients with sepsis and septic shock. Vitamin C therapy in combination with vitamin B1 and glucocorticoid, as well as monotherapy in various doses, has been investigated as a treatment for the vasoplegic state in sepsis, through targeting the inflammatory cascade. However, the combination effect and the relative contribution of each drug have not been well evaluated. Furthermore, the best combination between the three agents is currently unknown. We are planning a systematic review (SR) with network meta-analysis (NMA) to compare the different treatments and identify the combination with the most favourable effect on survival. METHODS AND ANALYSIS: We will include all randomised controlled trials comparing any intervention using intravenous vitamin C, vitamin B1 and/or glucocorticoid with another or with placebo in the treatment of sepsis. We are interested in comparing the following active interventions. Very high-dose vitamin C (≥12 g/day), high-dose vitamin C (≥6 g/day), vitamin C (<6 g/day); low-dose glucocorticoid (<400 mg/day of hydrocortisone (or equivalent)), vitamin B1 and combinations of the drugs above. The primary outcome will be all-cause mortality at the longest follow-up within 1 year but 90 days or longer postrandomisation. All relevant studies will be sought through database searches and trial registries. All reference selection and data extraction will be conducted by two independent reviewers. We will conduct a random-effects NMA to synthesise all evidence for each outcome and obtain a comprehensive ranking of all treatments. We will use the surface under the cumulative ranking curve and the mean ranks to rank the various interventions. To differentiate between the effect of combination therapies and the effect of a component, we will employ a component NMA. ETHICS AND DISSEMINATION: This SR does not require ethical approval. We will publish findings from this systematic review in a peer-reviewed scientific journal and present these at scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42018103860.


Asunto(s)
Corticoesteroides/uso terapéutico , Ácido Ascórbico/uso terapéutico , Choque Séptico/tratamiento farmacológico , Tiamina/uso terapéutico , Vasoplejía/tratamiento farmacológico , Corticoesteroides/administración & dosificación , Ácido Ascórbico/administración & dosificación , Quimioterapia Combinada , Humanos , Metaanálisis como Asunto , Metaanálisis en Red , Proyectos de Investigación , Choque Séptico/mortalidad , Revisiones Sistemáticas como Asunto , Tiamina/administración & dosificación , Resultado del Tratamiento
10.
Crit Care Resusc ; 21(4): 236-42, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31778629

RESUMEN

OBJECTIVES: To study vitamin C pharmacokinetics in septic shock. DESIGN: Prospective pharmacokinetic study. SETTING: Two intensive care units. PARTICIPANTS: Twenty-one patients with septic shock enrolled in a randomised trial of high dose vitamin C therapy in septic shock. INTERVENTION: Patients received 1.5 g intravenous vitamin C every 6 hours. Plasma samples were obtained before and at 1, 4 and 6 hours after drug administration, and vitamin C concentrations were measured by high performance liquid chromatography. MAIN OUTCOME MEASURES: Clearance, volume of distribution, and half-life were calculated using noncompartmental analysis. Data are presented as median (interquartile range [IQR]). RESULTS: Of the 11 participants who had plasma collected before any intravenous vitamin C administration, two (18%) were deficient (concentrations < 11 µmol/L) and three (27%) had hypovitaminosis C (concentrations between 11 and 23 µmol/L), with a median concentration 28 µmol/L (IQR, 11-44 µmol/L). Volume of distribution was 23.3 L (IQR, 21.9-27.8 L), clearance 5.2 L/h (IQR, 3.3-5.4 L/h), and half-life 4.3 h (IQR, 2.6-7.5 h). For the participants who had received at least one dose of intravenous vitamin C before sampling, T0 concentration was 258 µmol/L (IQR, 162- 301 µmol/L). Pharmacokinetic parameters for subsequent doses were a median volume of distribution 39.9 L (IQR, 31.4-44.4 L), clearance 3.6 L/h (IQR, 2.6-6.5 L/h), and half-life 6.9 h (IQR, 5.7-8.5 h). CONCLUSION: Intravenous vitamin C (1.5 g every 6 hours) corrects vitamin C deficiency and hypovitaminosis C and provides an appropriate dosing schedule to achieve and maintain normal or elevated vitamin C levels in septic shock.


Asunto(s)
Deficiencia de Ácido Ascórbico/tratamiento farmacológico , Ácido Ascórbico/farmacocinética , Enfermedad Crítica/terapia , Choque Séptico/tratamiento farmacológico , Vitaminas/farmacocinética , Administración Intravenosa , Ácido Ascórbico/administración & dosificación , Ácido Ascórbico/sangre , Deficiencia de Ácido Ascórbico/prevención & control , Biomarcadores/sangre , Cromatografía Líquida de Alta Presión , Relación Dosis-Respuesta a Droga , Humanos , Estudios Prospectivos , Choque Séptico/sangre , Choque Séptico/metabolismo , Vitaminas/administración & dosificación , Vitaminas/sangre
11.
Crit Care Resusc ; 21(2): 87-95, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31142238

RESUMEN

OBJECTIVE: To assess the effects of sepsis and exogenous insulin on C-peptide levels and C-peptide to insulin ratios in intensive care unit (ICU) patients with type 2 diabetes mellitus (T2DM). DESIGN, SETTING AND PARTICIPANTS: In this prospective, observational, single-centre study, we enrolled 31 ICU-admitted adults with T2DM. We measured serum C-peptide and insulin levels during the first 3 days of ICU stay and recorded characteristics of exogenous insulin therapy. Patients were compared on the basis of the presence of sepsis, and their exposure to exogenous insulin therapy. C-peptide levels were also measured in eight healthy subjects. MAIN OUTCOME MEASURES: Serum insulin and C-peptide levels during the first 3 days in ICU. RESULTS: Median C-peptide levels were higher in the ICU population compared with healthy subjects (10.9 [IQR, 8.2 -14.1] v 4.8 [IQR, 4.6-5.1] nmol/L, P < 0.01). Sepsis was present in 25 ICU patients (81%). Among ICU patients unexposed to exogenous insulin, the 11 patients with sepsis had higher median C-peptide levels compared with the six non-septic patients (2.5 [IQR, 1.8-3.7] v 1.7 [IQR, 0.8-2.2] nmol/L, P = 0.04), and a threefold higher C-peptide to insulin ratio (45 [IQR, 37-62] v 13 [IQR, 11-17], P = 0.03). However, septic patients exposed to exogenous insulin had lower median C-peptide levels (1.2 [IQR, 0.7-2.3] nmol/L, P = 0.01) and C-peptide to insulin ratios (5 [IQR, 2-10], P < 0.01) compared with insulin-free septic patients. The C-peptide to insulin ratio was significantly associated with white cell count and severity of illness in insulin-free septic patients. CONCLUSION: C-peptide levels were elevated in critically ill patients with T2DM. In this population, sepsis increased C-peptide levels and uncoupled serum C-peptide and insulin levels. Exogenous insulin decreased both C-peptide levels and C-peptide to insulin ratios.


Asunto(s)
Péptido C/sangre , Enfermedad Crítica , Diabetes Mellitus Tipo 2/complicaciones , Insulina/sangre , Unidades de Cuidados Intensivos , Sepsis/sangre , Adulto , Estudios de Casos y Controles , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/diagnóstico , Humanos , Estudios Prospectivos , Sepsis/etiología
12.
Crit Care Resusc ; 21(2): 119-125, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31142242

RESUMEN

BACKGROUND: Septic shock is associated with poor outcomes. Vitamin C (ascorbic acid) is a cellular antioxidant and has anti-inflammatory properties. Whether the combination therapy of vitamin C, thiamine and hydrocortisone reduces vasopressor dependency in septic shock is unclear. OBJECTIVES: To describe the protocol and statistical analysis plan of a multicentre, open-label, prospective, phase 2 randomised clinical trial evaluating the effects of vitamin C, thiamine and hydrocortisone when compared with hydrocortisone monotherapy on the duration of vasopressor administration in critically ill patients with septic shock. METHODS: VITAMINS is a multicentre cardiovascular efficacy trial in adult patients with septic shock. Randomisation occurs via a secure website with stratification by site, and allocation concealment is maintained throughout the trial. The primary outcome is the duration of time alive and free of vasopressor administration at Day 7. Secondary outcomes include feasibility endpoints and some patientcentred outcomes. All analyses will be conducted on an intention-to-treat basis. CONCLUSION: The VITAMINS trial will determine whether combination therapy of vitamin C, thiamine and hydrocortisone when compared with hydrocortisone increases vasopressor-free hours in critically ill patients with septic shock. The conduct of this study will provide important information on the feasibility of studying this intervention in a phase 3 trial. TRIAL REGISTRATION: ClinicalTrials.gov, identification No. NCT03333278.


Asunto(s)
Ácido Ascórbico/administración & dosificación , Mortalidad Hospitalaria , Hidrocortisona/administración & dosificación , Choque Séptico/tratamiento farmacológico , Tiamina/administración & dosificación , Vitaminas/administración & dosificación , Adulto , Ácido Ascórbico/uso terapéutico , Quimioterapia Combinada , Femenino , Humanos , Hidrocortisona/uso terapéutico , Unidades de Cuidados Intensivos , Masculino , Estudios Prospectivos , Choque Séptico/mortalidad , Tiamina/uso terapéutico , Resultado del Tratamiento , Vasoconstrictores/uso terapéutico , Vitaminas/uso terapéutico
13.
Crit Care Resusc ; 21(1): 9-17, 2019 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-30857507

RESUMEN

OBJECTIVE: Despite the growing number of older patients having major surgery, the normal resting values for the cardiac index of older patients remain unclear. We aim to derive a normative value for such patients. DESIGN: Scoping review. DATA SOURCES: We searched MEDLINE, EMBASE and CENTRAL for studies reporting measured values of cardiac output or cardiac index in healthy, older humans at rest. RESULTS: We retrieved 5340 citations and assessed 412 fulltext articles for eligibility. Twenty-nine studies, published between 1964 and 2017, met our inclusion criteria. Overall, the mean cardiac index in healthy volunteers over 60 years of age was reported between 2.1 and 3.2 L/min/m2 and the mean cardiac output was between 3.1 and 6.4 L/min. A yearly decline in cardiac index (between 3.5 and 8 mL/min/m2 per year) was reported in some but not all studies. Only one study measured the cardiac index in nine people over 80 years of age. CONCLUSIONS: The normal range of the cardiac index in older patients may be lower than previously reported. Its rate of decline with age is uncertain, but likely between 3.5 and 8 mL/min/m2 per year. Data on the normal cardiac index in people older than 80 years are scant.


Asunto(s)
Gasto Cardíaco/fisiología , Frecuencia Cardíaca/fisiología , Función Ventricular Izquierda/fisiología , Anciano de 80 o más Años , Humanos
14.
Acta Anaesthesiol Scand ; 63(6): 761-768, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-30882892

RESUMEN

BACKGROUND: Critically ill patients with diabetes mellitus (DM) are at increased risk of in-hospital complications and the optimal glycemic target for such patients remains unclear. A more liberal approach to glucose control has recently been suggested for patients with DM, but uncertainty remains regarding its impact on complications. METHODS: We aimed to test the hypothesis that complications would be more common with a liberal glycemic target in ICU patients with DM. Thus, we compared hospital-acquired complications in the first 400 critically ill patients with DM included in a sequential before-and-after trial of liberal (glucose target: 10-14 mmol/L) vs conventional (glucose target: 6-10 mmol/L) glucose control. RESULTS: Of the 400 patients studied, 165 (82.5%) patients in the liberal and 177 (88.5%) in the conventional-control group were coded for at least one hospital-acquired complication (P = 0.09). When comparing clinically relevant complications diagnosed between ICU admission and hospital discharge, we found no difference in the odds for infectious (adjusted odds ratio [aOR] for liberal-control: 1.15 [95% CI: 0.68-1.96], P = 0.60), cardiovascular (aOR 1.40 [95% CI: 0.63-3.12], P = 0.41) or neurological complications (aOR: 1.07 [95% CI: 0.61-1.86], P = 0.81), acute kidney injury (aOR 0.83 [95% CI: 0.43-1.58], P = 0.56) or hospital mortality (aOR: 1.09 [95% CI: 0.59-2.02], P = 0.77) between the liberal and the conventional-control group. CONCLUSION: In this prospective before-and-after study, liberal glucose control was not associated with an increased risk of hospital-acquired infectious, cardiovascular, renal or neurological complications in critically ill patients with diabetes.


Asunto(s)
Glucemia/análisis , Complicaciones de la Diabetes/etiología , Diabetes Mellitus/terapia , Unidades de Cuidados Intensivos , Anciano , Enfermedad Crítica , Femenino , Hemoglobina A Glucada/análisis , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
15.
Intensive Care Med ; 44(11): 1797-1806, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30343313

RESUMEN

PURPOSE: We set out to assess the resuscitation fluid requirements and physiological and clinical responses of intensive care unit (ICU) patients resuscitated with 20% albumin versus 4-5% albumin. METHODS: We performed a randomised controlled trial in 321 adult patients requiring fluid resuscitation within 48 h of admission to three ICUs in Australia and the UK. RESULTS: The cumulative volume of resuscitation fluid at 48 h (primary outcome) was lower in the 20% albumin group than in the 4-5% albumin group [median difference - 600 ml, 95% confidence interval (CI) - 800 to - 400; P < 0.001]. The 20% albumin group had lower cumulative fluid balance at 48 h (mean difference - 576 ml, 95% CI - 1033 to - 119; P = 0.01). Peak albumin levels were higher but sodium and chloride levels lower in the 20% albumin group. Median (interquartile range) duration of mechanical ventilation was 12.0 h (7.6, 33.1) in the 20% albumin group and 15.3 h (7.7, 58.1) in the 4-5% albumin group (P = 0.13); the proportion of patients commenced on renal replacement therapy after randomization was 3.3% and 4.2% (P = 0.67), respectively, and the proportion discharged alive from ICU was 97.4% and 91.1% (P = 0.02). CONCLUSIONS: Resuscitation with 20% albumin decreased resuscitation fluid requirements, minimized positive early fluid balance and was not associated with any evidence of harm compared with 4-5% albumin. These findings support the safety of further exploration of resuscitation with 20% albumin in larger randomised trials. TRIAL REGISTRATION: http://www.anzctr.org.au . Identifier ACTRN12615000349549.


Asunto(s)
Albúminas/administración & dosificación , Cuidados Críticos/métodos , Fluidoterapia/métodos , Resucitación/métodos , Adulto , Anciano , Australia , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reino Unido , Equilibrio Hidroelectrolítico
17.
Crit Care Med ; 46(6): 935-942, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29509570

RESUMEN

OBJECTIVES: To assess the feasibility, biochemical efficacy, and safety of liberal versus conventional glucose control in ICU patients with diabetes. DESIGN: Prospective, open-label, sequential period study. SETTING: A 22-bed mixed ICU of a tertiary hospital in Australia. PATIENTS: We compared 350 consecutive patients with diabetes admitted over 15 months who received liberal glucose control with a preintervention control population of 350 consecutive patients with diabetes who received conventional glucose control. INTERVENTIONS: Liberal control patients received insulin therapy if glucose was greater than 14 mmol/L (target: 10-14 mmol/L [180-252 mg/dL]). Conventional control patients received insulin therapy if glucose was greater than 10 mmol/L (target: 6-10 mmol/L [108-180 mg/dL]). MEASUREMENTS AND MAIN RESULTS: We assessed separation in blood glucose, insulin requirements, occurrence of hypoglycemia (blood glucose ≤ 3.9 mmol/L [70 mg/dL]), creatinine and white cell count levels, and clinical outcomes. The median (interquartile range) time-weighted average blood glucose concentration was significantly higher in the liberal control group (11.0 mmol/L [8.7-12.0 mmol/L]; 198 mg/dL [157-216 mg/dL]) than in the conventional control group (9.6 mmol/L [8.5-11.0 mmol/L]; 173 mg/dL [153-198 mg/dL]; p < 0.001). Overall, 132 liberal control patients (37.7%) and 188 conventional control patients (53.7%) received insulin in ICU (p < 0.001). Hypoglycemia occurred in 6.6% and 8.6%, respectively (p = 0.32). Among 314 patients with glycated hemoglobin A1c greater than or equal to 7%, hypoglycemia occurred in 4.1% and 9.6%, respectively (p = 0.053). Trajectories of creatinine and white cell count were similar in the groups. In multivariable analyses, we found no independent association between glucose control and mortality, duration of mechanical ventilation, or ICU-free days to day 30. CONCLUSIONS: In ICU patients with diabetes, during a period of liberal glucose control, insulin administration, and among patients with hemoglobin A1c greater than or equal to 7%, the prevalence of hypoglycemia was reduced, without negatively affecting serum creatinine, the white cell count response, or other clinical outcomes. (Trial Registration: Australian New Zealand Clinical Trials Registry; ACTRN12615000216516).


Asunto(s)
Glucemia/análisis , Diabetes Mellitus Tipo 2/sangre , Unidades de Cuidados Intensivos , Anciano , Estudios Controlados Antes y Después , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/terapia , Femenino , Hemoglobina A Glucada/análisis , Humanos , Hipoglucemia/epidemiología , Hipoglucemia/prevención & control , Masculino , Persona de Mediana Edad , Estudios Prospectivos
20.
Crit Care Resusc ; 19(2): 142-149, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28651510

RESUMEN

OBJECTIVE: To assess the physiological, biochemical and haemodynamic response to a single intravenous (IV) dose of frusemide in critically patients. DESIGN, SETTING AND PATIENTS: A prospective observational study of 21 critically ill patients in a tertiary intensive care unit in Australia. INTERVENTIONS: We collected information on urine output (UO), fluid balance, serum and urinary electrolyte levels, serum biochemical levels and haemodynamics. We compared data from the 6-hour period before administration of a single IV bolus of frusemide 40 mg with data from the 6-hour period after administration. RESULTS: We studied 21 patients (12 of whom were women) with a median age of 73 years (interquartile range [IQR], 64-80 years). The IV bolus induced a > 1000 mL increase in UO in six patients (28.6%); a 500-1000 mL increase in six patients (28.6%) and a < 500 mL increase in nine patients (42.8%). The median difference in UO before and after frusemide was 590 mL (IQR, 290-1111 mL). The 6-hour fluid balance became negative in 15 patients (71.4%) and positive in six patients (28.6%), with a median change of -595 mL (IQR, -880 to 98 mL). Frusemide significantly increased urinary sodium, potassium and chloride losses and decreased blood chloride levels. There were no detectable changes in haemodynamics. On linear regression analysis, sodium excretion and UO correlated with higher mean arterial pressure (MAP) and age, and with lower albumin and creatinine levels. CONCLUSIONS: In a cohort of critically ill patients without chronic renal impairment, frusemide increased UO and urinary sodium, potassium and chloride losses, and induced hypochloraemia and metabolic alkalosis. However, its diuretic effects were extremely variable and were modified by age, MAP and creatinine and albumin levels.


Asunto(s)
Enfermedad Crítica/terapia , Furosemida/farmacología , Furosemida/farmacocinética , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico/farmacología , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico/farmacocinética , Anciano , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Electrólitos/sangre , Femenino , Furosemida/administración & dosificación , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico/administración & dosificación , Urodinámica/efectos de los fármacos , Equilibrio Hidroelectrolítico/efectos de los fármacos
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