Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cirrhosis as diagnosed by clinical, biochemical,ultrasound, endoscopy finding and or liver biopsy if needed. 2. Age 18years to 75 years 3. Diagnosis of type 1 HRS AKI as defined by the criteria of the International Club of Ascites ICA The following criteria will be followed for the diagnosisof HRS AKI a. Cirrhosis with ascites, b. Increase in serum creatinine 0.3 mg per dL within 48 hours or 50 percent frombaseline value, known or presumed, to have occurred within the prior 7 days and or urine output less than 0.5 mL per kg for 6 hr. c Absence of improvement in serum creatinine and or urine output within 24 hours following adequate volume resuscitation when clinicallyindicated and d. Absence of strong evidence for an alternative explanation as theprimary cause of AKI.
Exclusion criteria
Exclusion criteria: Following cirrhoticpatients were excluded: (1) Hepatocellularcarcinoma . (2) Septic shock; (3) Cardiac or respiratory failure or other severe extrahepatic disease; or (4) Contraindications to the use ofterlipressin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of terlipressin infusion in comparison to terlipressin bolus injection for achieving complete response in patients of cirrhosis with HRS -AKI â?¢ Complete response is defined as decline in serum creatinine less than 1.5 mg/dl. Timepoint: Primary outcome will be assessed at any time when complete response is achieved after start of treatment till the end of treatment at 14 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the development of terlipressin induced adverse event between the two groups 2. To compare the 90-day transplant-free survival between two groups. Timepoint: secondary outcome will be assessed at 90 days | — |
Countries
India
Contacts
Department of Hepatology