''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure'
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Response to treatment in each intervention group
Study Overview
Brief Summary
Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury
Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed.
If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with acute on chronic liver failure presenting with hepatorenal syndrome
- •Patients consented for the study protocol by signing the informed consent.
Exclusion Criteria
- •Age less than 18 years
- •Decompensated cirrhotics
- •Evidence of chronic kidney disease
- •Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation).
- •Post liver transplantation patients.
- •History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
- •Patients with obstructive uropathy.
- •Patient who withdrew or non complaint to the study protocol.
Arms & Interventions
Nor Adrenaline + Albumin
Intravenous continous infusion of terlipressin at the dose of 2 mg every 24 hours with the maximum daily cumulative dose of 12 mg/day.
In case of no response the dose of the terlipressin will be progressively increased to the maximum infusion dose of 12 mg/24 hour.
Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.
Intervention: Nor adrenaline + albumin (Drug)
Terlipressin + Albumin
Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours designed to achieve an increase in MAP of at least 10 mmHg or an increase in 4-h urine output of more than 200 ml. When one of these goals was not achieved, the noradrenaline dose was increased every 4 h in steps of 0.5 mg/h, up to the maximum dose of 3 mg/h.
Patients will be given 1g/Kg of albumin per day, which will be discontinued if CVP is more than 18 cm H2O.
Intervention: Terlipressin + albumin (Drug)
Outcomes
Primary Outcomes
Response to treatment in each intervention group
Time Frame: 14 days
Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury.
Secondary Outcomes
- Drug related Side effects/complications(28 days)
- Survival(28 days)