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Safety and Efficacy of CRRT (Medical therapy)in Patients With Acute Liver Failure (Liver Disease).

To Evaluate the Safety and Efficacy of Preemptive Administration of Continuous Renal Replacement Therapy in Patients With Acute Liver Failure With Cerebral Edema -A Prospective Randomized Controlled Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034577
Enrollment
60
Registered
2021-07-05
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: K729- Hepatic failure, unspecified

Interventions

Intervention1: Preemptive CRRT: Continuous renal replacement therapy will be administered as continuous venovenous hemodiafiltration (CVVHDF) using Prisma and Prismaflex (Gambro) devices, with blood f

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with acute liver failure defined patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease with documented cerebral edema on CT-scan and arterial ammonia >150 ug/dL.

Exclusion criteria

Exclusion criteria: 1. Age 70 years 2. Hepatocellular Carcinoma 3. Active untreated Sepsis/DIC 4. Hemodynamic instability requiring high dose of vasopressors 5. Post-resection and malignancy related liver failure 6. Coma of non-hepatic origin 7. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis 8. Patients already meeting emergency criteria for immediate initiation of dialysis at the time of randomization (serum potassium >6 meq/lt, metabolic acidosis ph 9. Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit 10. Extremely moribund patients with an expected life expectancy of less than 24 hours 11. Pregnancy related liver failure 12. Patients with significant renal dysfunction meeting absolute criteria for initiation of dialysis 13. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease) 14. Patients being taken up for liver transplant 15. Refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
Transplant free survivalTimepoint: Day 21

Secondary

MeasureTime frame
Duration of mechanical ventilation and ICU stayTimepoint: 2 years;Effect on endotoxin, DAMPS, pro-inflammatory cytokines, endothelial functions and coagulationTimepoint: 2 years;Effect on systemic hemodynamics and pulmonary function.Timepoint: 24 hours,Day 5 and Day 14;Impact on arterial lactateTimepoint: 6 hours,12 hours, 24 hours,Day 5 and day 14;Improvement in cerebral edema and hepatic encephalopathy.Timepoint: Day 5 and day 14;Improvement in SIRSTimepoint: Day 5;To study the safety of therapy (incidence of intradialytic hypotension, impairment of coagulation, hypothermia).Timepoint: 2 years

Countries

India

Contacts

Public ContactDr Rakhi Maiwall

Institute of Liver and Biliary Sciences

rakhi_2011@yahoo.co.in

Outcome results

None listed

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