Status:
COMPLETED
Efficacy of Vitamin C on AKI Outcomes in Critically Ill Cirrhotics With Multidrug-resistant Bacterial Infections.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 vita...
Detailed Description
Aim \& Objectives Primary To evaluate the impact of vitamin C on AKI outcomes in patients with cirrhosis and MDR infections Secondary Objectives To assess the effects on systemic hemodynamics (cardia...
Eligibility Criteria
Inclusion
- \- Critically ill cirrhotics with MDR infections
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04494451
Start Date
September 15 2021
End Date
November 2 2022
Last Update
November 3 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070