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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a continuous infusion of a medication called terlipressin, combined with norepinephrine, can improve outcomes for patients suffering from acute kidney injury due to acute on chronic liver failure and septic shock. Septic shock is a serious condition where the body’s response to infection leads to dangerously low blood pressure. Norepinephrine is commonly used to help raise blood pressure, but this trial aims to see if adding terlipressin can provide additional benefits.

To participate in this trial, patients must be over 18 years old and under 60, have been diagnosed with acute on chronic liver failure, and be experiencing acute kidney injury along with needing norepinephrine to manage their blood pressure. Patients with certain conditions, such as severe heart or kidney issues, or those who have received terlipressin recently, will not be eligible. Participants will receive close monitoring and care throughout the trial, helping researchers determine the safety and effectiveness of this treatment combination.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age\>18 years and \<60 yrs
• • 2. ACLF as per APASL
• • 3. AKI according to KDIGO Criteria
• • 4. septic shock requiring norepinephrine (\<0.05mcg/kg/min).
• Exclusion Criteria:
• • 1. Septic shock requiring 2 vasopressors (Norephinephrine reuirement \> 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 \< 400 ml /day or obstructive uropathy
• • 10. History of immunosuppressive drugs
• • 11. Pregnancy
• • 12. Human immunodeficiency virus 1 and 2
• • 13. Portal vein thrombus