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Assessment of safety and efficacy of triple regimen in Acute on chronic liver failure ( ACLF ) patients with large ascites and acute kidney injury with slow albumin ,furosemide and vasoconstrictors therapy versus albumin and vasoconstrictors and oral dirutics

Comparison of outcome of Acute on chronic liver failure ( ACLF ) patients with large ascites and acute kidney injury with slow albumin, vasoconstrictors(terlipressin) and i.v. diuretics(furosemide) therapy versus albumin and vasoconstrictors (Terlipressin) and oral diuretics(furosemide)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024521
Enrollment
60
Registered
2020-04-08
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 Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Intravenous infusion of furosemide with continuous infusions of albumin and vasoconstrictors in both group as per protocol: Furosemide (Lasix) infusion shall be started at the rate of

Sponsors

Institutional Ethics Committee Sanjay Gandhi Institute of Medical Sciences Lucknow
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: b.ACLF as per EASL- CLIF definition, 2013 c.AKI-HRS as per ICA 2007 definition (reduction in renal function was defined as SCr >=226 lmol/L and/or a doubling of SCr within 2 weeks with patients have no sustained improvement in renal function during the pre-enrolment screening). All patients will undergo fluid challenge with intravenous albumin to demonstrate that volume expansion was insufficient to correct renal failure, and specific inclusion criteria will be applied for the SCr response 48 h after diuretic withdrawal and albumin administration ( =199 lmol/L)

Exclusion criteria

Exclusion criteria: a.CKD G5; eGFR b.Patient with AKI-HRS who has already underwent hemodialysis before enrollment c.Severe cardiopulmonary disease, terminal cancer d.Patient with HCC on screening ultrasound e.Patient with portal/superior mesentric vein thrombosis on screening ultrasound f.Ongoing shock or uncontrolled bacterial infection. g. Patients receiving octreotide, midodrine, vasopressin, dopamine or other vasopressors within 48 h, as well as h. patients who received

Design outcomes

Primary

MeasureTime frame
a.End of treatment: i.Reversal of HRS ii.complete ascites mobilization b.End point of the study will be i.death, ii.Liver transplantation or iii.completion of 1 month of follow-up Timepoint: 1 month

Secondary

MeasureTime frame
.End point of the study will be i.death, ii.Liver transplantation or iii.completion of 1 month of follow-up Timepoint: 1 month

Countries

India

Contacts

Public ContactGaurav Pande

SGPGI MS Lucknow

drgauravpandey@yahoo.com9170689999

Outcome results

None listed

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