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

NCT04494451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

Vit C

vitamin C (25 mg/kg or max. 1.5 gram every 6 hourly) for maximum 5 day

DRUG

Standard medical Treatment

iv antibiotics alone

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494451 on ClinicalTrials.gov