Status:
COMPLETED
Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Type 1 HEPATO RENAL SYNDROME(HRS)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Hepatorenal syndrome (HRS) is defined as a functional renal failure in a patient with chronic liver disease, or liver cirrhosis.The splanchnic circulation undergoes severe vasodilation, as a result of...
Eligibility Criteria
Inclusion
- age\>18 years and \<80 yrs;
- Cirrhosis as diagnosed by clinical findings, endoscopy or USG examination or by liver biopsy.
- HRS I as defined by the following features:
- The patient should have Cirrhosis and also ascites
- Renal failure of rapid onset -Initial value of sCr, doubling to reach a level of more than 226mmol/L (2.5 mg/dL) in less than two weeks
- There should be absence of shock.
- sCr value does not reduce to less than 1.5 mg/dl even after 2 days of stopping diuretics and giving Inj.Albumin for plasma volume expansion (1g/kg ) upto 100g/day.
- No H/O being treated currently or recently with drugs having nephrotoxicity.
- Absence of parenchymal renal disease:
- Proteinuria \< 0.5g/day
- Absence of microhaematuria (\<50 red cells/high powered field)
- Normal renal ultrasonography
Exclusion
- AKI improved after plasma volume expansion
- Any history of coronary artery disease, peripheral vascular disease, arrhythmias, and cardiomyopathy.
- Hepatocellular Carcinoma
- Septic shock
- Any severe extra-hepatic condition including respiratory and cardiac failure.
- Any contraindication which precludes the use of Noradrenaline and Terlipressin
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03822091
Start Date
January 28 2019
End Date
January 30 2020
Last Update
May 9 2023
Active Locations (1)
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1
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012