An interventional study of nor adrenaline and terlipressin and step up terlipressin therapy in Hepatorenal Syndrome, sponsored by Institute of Liver and Biliary Sciences, India. Withdrawn at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-31.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study.
The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.
53 studies on the registry are indexed under Hepatorenal Syndrome; 7 are open to participants now.
Browse Hepatorenal Syndrome studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.
Drug: nor adrenaline and terlipressin
Drug: step up terlipressin therapy
IV bolus terlipressin at the dose of 0.5 to 1 mg every 6 hours with the maximum daily cumulative dose of 4 mg/day. Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours in case of no response.\[ No response defined as MAP \< 10, or 4 hr Urine output \< 200 ml\] with maximum dose upto 3 mg/h.
IV bolus terlipressin starting at 1.5 mg every 6 hours with increase in dose by 0.5 mg/6 hours in case of no response \[\< 25% decrease in s.creatinine\] after every 48 hours. Maximum daily cumulative dose of 12 mg/day.
the Response to treatment in each intervention group
Time frame: 2 years
Survival
Time frame: 15 days
Side effects of the drug
Time frame: 3 months
Complications and the predictors of the treatment response
Time frame: 2 years
This study is withdrawn, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India