drugset / Trial / NCT04494451

Efficacy of Vitamin C on AKI Outcomes in Critically Ill Cirrhotics With Multidrug-resistant Bacterial Infections.

NCT04494451

RandomizedParallel-groupOpen-labelTreatment

Summary

In this prospective randomized controlled trial we aim to evaluate the impact of vitamin C on AKI outcomes in patients with cirrhosis and MDR infections. We also aim to evaluate the effects of iv vitamin c on systemic hemodynamics (cardiac output and systemic vascular resistive index, extravascular lung water and lung permeability index), endothelial function and coagulation, microcirculation (as assessed by lactate clearance and central venous oxygen saturation), mitochondrial function, 28-day mortality and vasopressor, ventilator and RRT free days in the ICU. The safety and side-effects of vitamin c would also be evaluated. Patients with suspected (nosocomial acquisition) or proven MDR infections would be screened and randomized to two groups who meet the inclusion and exclusion criteria. Group 1: Will receive iv vitamin C (25 mg/kg or max. 1.5 gram every 6 hourly) for maximum 5 days along with iv antibiotics as per institutional protocol Group 2: iv antibiotics alone

Timeline

Start
2021-09-15
Primary completion
2022-11-02
Completion
2022-11-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 25 mg/kg Intravenous
Subject Vitamin C Other / unclassified 1.5 g Intravenous

Indications