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

• Status: Not yet recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Criteria

Inclusion Criteria:

• Critically ill cirrhotics with MDR infections

Exclusion Criteria:

• 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

• Patients with refractory septic shock or hypoxemia (Pa02/Fio2 ratio <100)

• Extremely moribund patients with an expected life expectancy of less than 24 hours

• Failure to provide informed consent

• Patients with retroviral infection

• Patients with acute on chronic liver failure (APASL definition)

• Patients with urinary tract infection