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A study on the use of drugs like noradrenaline and vasopressin in managing hepatorenal issues associated with chronic liver disease

Noradrenaline versus Terlipressin for Acute kidney injury due to Hepato renal syndrome:An open Label, Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067954
Enrollment
111
Registered
2024-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Terlipressin: Intravenous infusion, with dosages starting at 3 mg every twenty four hour infusion. Control Intervention1: Nor adrenaline: Initial starting dose will be calculated by pat

Sponsors

Department of GI Surgery Amrita Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient diagnosed withHRS-AKI at our hospital. The following inclusion criteria were applied: 1. Age between 18 and 70 years; 2. Satisfying the revised diagnostic criteria of HRS listed by the International Ascites Club, namely, cirrhosis with ascites; 3. Acute kidney injury according to new International Club of Ascites Criteria. 4. Absence of renal function recovery(return of serum creatinine to a final value upto 0.3mg/dL above the baseline) that did not improve within 48 hours of diuretic withdrawal and volume expansion with albumin; 5. Absence of shock; 6. No current or recent treatment with nephrotoxic drugs; 7. No findings of parenchymal renal disease(suggested by proteinuria >500mg/24hours or hematuria >50 RBC/HPF) or obstructive uropathy on laboratory and ultrasound assessment;

Exclusion criteria

Exclusion criteria: 1. History of coronary disease; 2. Evidence of ventricular arrhythmia or cardiomyopathy obtained based on history taking, risk factor evaluation, physical examination, echocardiography, and radiography. 3. History of adverse effects to any of these drugs or allergic to terlipressin. 4. Patient on Ionotropic supports. 5. Non HRS-AKI.

Design outcomes

Primary

MeasureTime frame
and rapid improvement in renal function (reduction in serum creatinine levels, increase in creatinine clearance & urine output), as well as by a large increase in Mean arterial pressure and serum sodium concentrationTimepoint: 48 hrs after treatment

Secondary

MeasureTime frame
1. Mortality as well as progression of patients to Liver Transplantation 2.Cost effectiveness Timepoint: Post 48 hrs

Countries

India

Contacts

Public ContactMallika Singh

Amrita Institute of Medical Sciences and Research Centre

sudhisalini@icloud.com9388623851

Outcome results

None listed

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