Efficacy of Vitamin C on liver disease With Multidrug-resistant Bacterial Infections.
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2020/09/027527
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Critically ill cirrhotics with MDR infections
1.Patients with age less than 18 years
2.Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
3.Patients in DIC with platelets < 20,000 and INR > 4 or active bleeding
4.Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including do not intubate (DNI) status
5.Current hospitalization > 15 days for patients with nosocomial acquisition of MDR at time of randomization
6.Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion,
7.Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
8.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
9.Patients with HCC (beyond Milan) or extrahepatic malignancies
10.Patients with HVOTO or EHPVO
11.Pregnancy or active breastfeeding
12.Current participation in another interventional research study
13.Active or history of kidney stone
14.History of chronic kidney disease or intrinsic kidney disease
15.Patients already on maintenance hemodialysis prior to presentation
16.Patients with refractory septic shock or hypoxemia (Pa02/Fio2 ratio <100)
17.Extremely moribund patients with an expected life expectancy of less than 24 hours
18.Failure to provide informed consent
19.Patients with retroviral infection
20.Patients with acute on chronic liver failure (APASL definition)
21.Patients with urinary tract infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AKI progression at Day 5Timepoint: Day 5
- Secondary Outcome Measures
Name Time Method actate clearance in both groupsTimepoint: 12 and 24 Hours;Mortality in both groupsTimepoint: Day 28;Time to reversal of AKI in both groupsTimepoint: Day 14;Vasopressor, ventilator and days free of dialysis during ICU stayTimepoint: Day 28