Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Acute on Chronic Liver Failure
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL i...
Detailed Description
• Aim: To study the safety and efficacy of low-dose continuous infusion of terlipressin with norepinephrine compared to norepinephrine alone in improving outcomes of Acute kidney injury occurring in t...
Eligibility Criteria
Inclusion
- Age\>18 years and \<60 yrs
- ACLF as per APASL
- AKI according to KDIGO Criteria
- septic shock requiring norepinephrine (\<0.05mcg/kg/min).
Exclusion
- Septic shock requiring 2 vasopressors (Norephinephrine reuirement \> 0.05mcg/kg/min)
- Symptomatic cardiopulmonary disease
- Chronic kidney disease
- Peripheral vascular disease
- Hepatocellular carcinoma outside Milan criteria
- Prior use of terlipressin in last 48 hours
- Patients with hypovolemic or hemorrhagic shock
- Patients already meeting criteria for dialysis or with history of dialysis in last 7 days
- Intrinsic kidney disease, Acute tubular necrosis with urinary output \< 400 ml /day or obstructive uropathy
- History of immunosuppressive drugs
- Pregnancy
- Human immunodeficiency virus 1 and 2
- Portal vein thrombus
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06556472
Start Date
August 15 2024
End Date
August 31 2025
Last Update
August 16 2024
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070