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Efficacy of Vitamin C on liver disease With Multidrug-resistant Bacterial Infections.

Efficacy of Vitamin C on AKI Outcomes in Critically Ill Cirrhotics With Multidrug-resistant Bacterial Infections- A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027527
Enrollment
100
Registered
2020-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Vitamin C with Standard Medical Treatment: Dose:vitamin C (25 mg per kg or max. 1.5 gram every 6 hourly) Frequency: Every 6 hourly Route of Administration: Intravenous Duration:5 days

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Critically ill cirrhotics with MDR infections

Exclusion criteria

Exclusion criteria: 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 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 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

Design outcomes

Primary

MeasureTime frame
AKI progression at Day 5Timepoint: Day 5

Secondary

MeasureTime frame
Lactate 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

Countries

India

Contacts

Public ContactDr Rakhi Maiwall

Institute of Liver and Biliary Sciences

rakhi_2011@yahoo.co.in01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026