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Comparison of two medicines terlipressin and noradrenaline in liver failure patient who is having low blood pressure and increased creatinine.

Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock - A Randomised Controlled Trial. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073738
Enrollment
126
Registered
2024-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: N29- Other disorders of kidney and ureter in diseases classified elsewhere

Interventions

Intervention1: Continuous terlipressin infusion and Norepinephrine: 1. Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if targ

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ACLF as per APASL 2. AKI according to KDIGO Criteria 3. septic shock requiring norepinephrine (less tha 0.05mcg per kg per min).

Exclusion criteria

Exclusion criteria: 1. Septic shock requiring 2 vasopressors (Norephinephrine requirement more than 0.05mcg/kg/min) 2. Symptomatic cardiopulmonary disease 3. Chronic kidney disease 4. Peripheral vascular disease 5. Hepatocellular carcinoma outside Milan criteria 6. Prior use of terlipressin in last 48 hours 7. Patients with hypovolemic or hemorrhagic shock 8. Patients already meeting criteria for dialysis or with history of dialysis in last 7 days 9. Intrinsic kidney disease, Acute tubular necrosis with urinary output less than 400 ml /day or obstructive uropathy 10. History of immunosuppressive drugs 11. Pregnancy 12. Human immunodeficiency virus 1 and 2 13. Portal vein thrombus

Design outcomes

Primary

MeasureTime frame
Proportion of patients developing 1 stage improvement in Acute kidney injury stage with resolution of shock at day 4 in both groupsTimepoint: Day 4

Secondary

MeasureTime frame
Outcome (resolution, persistence or progreession) of acute kidney injury at day 4,7Timepoint: Day 4 & 7;Incidence of adverse events in both groupsTimepoint: 1 year;Need of renal replacement therapy at day 7Timepoint: Day 7;Duration of ICU and hospital stayTimepoint: 1 year;MortalityTimepoint: Day 7 and 28

Countries

India

Contacts

Public ContactDr Rakhi Maiwall

Institute of Liver and Biliary Sciences

rakhi_2011@yahoo.co.in01146300000

Outcome results

None listed

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