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

NCT04494451 | Completed

• 1 other identifier: ILBS-Cirrhosis-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• AKI progression at day 5

  Day 5

Secondary Outcomes (5)

• Mortality in both groups

  Day 28

• Time to reversal of AKI in both groups

  Day 14

• Lactate clearance in both groups

  12 hours

• Lactate clearance in both groups

  24 hours

• Vasopressor, ventilator and days free of dialysis during ICU stay

  Day 28

Study Arms (2)

Vitamin C + Standard Medical Treatment

EXPERIMENTAL

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 along with iv antibiotics

Drug: Vit C; Drug: Standard medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

iv antibiotics alone

Drug: Standard medical Treatment

Interventions

Vit C DRUG

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

Vitamin C + Standard Medical Treatment

Standard medical Treatment DRUG

iv antibiotics alone

Standard Medical Treatment; Vitamin C + Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Critically ill cirrhotics with MDR infections

You may not qualify if:

• Patients with age less than 18 years
• Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
• Patients in DIC with platelets \< 20,000 and INR \> 4 or active bleeding
• Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" (DNI) status
• Current hospitalization \> 15 days for patients with nosocomial acquisition of MDR at time of randomization
• Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion,
• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
• Use of vitamin C at a dose of \> 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission
• Patients with HCC (beyond Milan) or extrahepatic malignancies
• Patients with HVOTO or EHPVO
• Pregnancy or active breastfeeding
• Current participation in another interventional research study
• Active or history of kidney stone
• History of chronic kidney disease or intrinsic kidney disease
• Patients already on maintenance hemodialysis prior to presentation

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 15, 2021
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

IN (1)