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

Not Applicable

• Conditions: Health Condition 1: K729- Hepatic failure, unspecified

• Registration Number: CTRI/2021/07/034577
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

1.Age <18 or > 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 <7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant free survivalTimepoint: Day 21

Secondary Outcome Measures

Name	Time	Method
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