A Phase 3 interventional study of Terlipressin and Terlipressin and Noradrenaline in Type 1 HEPATO RENAL SYNDROME(HRS), sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 3, Interventional, and Treatment
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 portal hypertension, causing an underfilling of systemic arteries.This results in intense renal vasoconstriction and functional renal failure. The best treatment options for HRS I would be a drug which has renal vasodilator property and additional splanchnic vasoconstriction. An increase in circulating blood volume would be of additional benefit. Currently Terlipressin is considered superior to other drugs in the management of HRS I. Other drugs in use are Noradrenaline and Midodrine. Albumin is added to these drugs in order to expand plasma volume. Terlipressin, a Vasopressin analog, has agonistic activity at V1 receptors. Noradrenaline acts as an agonist at α-adrenergic receptors with mild β-agonistic activity. The two major drugs used in the management of HRS act at different receptors and have completely varied mechanisms of action. Thus, a combination therapy would improve the rate of response considerably. There have been multiple studies, measuring the efficacy, safety and dosing of both drugs, but none combining both Terlipressin and Noradrenaline. Hence our study would be a pioneer in formulating a new and possibly more efficacious treatment protocol for patients of Type I HRS, in whom the treatment options are otherwise very limited. If successful, this would open new horizons of therapy for Terlipressin refractory HRS, which, otherwise is an ominous condition.
53 studies on the registry are indexed under Hepatorenal Syndrome; 7 are open to participants now.
This study's enrollment of 60 is above the median of 54 across 39 interventional studies indexed under Hepatorenal Syndrome.
Browse Hepatorenal Syndrome studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
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HRS I as defined by the following features:
Absence of parenchymal renal disease:
Exclusion Criteria:
Drug: Terlipressin
Drug: Terlipressin and Noradrenaline
Patients with Type 1 HRS will be given Terlipressin at the dose of 2mg/24 hrs as infusion. After 48 hours of initial monitoring, patients who do not respond to the initial dose of Terlipressin, and randomised into group A and B. Group A patients will receive further higher doses of Terlipressin. The dose of Terlipressin will be increased by 1mg after 24 hrs if: * the creatinine values decrease by \<12.5% * MAP increase of \<10 mmHg * urine output of \<200 ml in 4 hours. Maximum terlipressin dose will be given upto 12 mg/day.Albumin will be administered in both arms according to standard protocol at the following dose : 1. 1st day - Albumin at 1 gram/kg - a maximum dose of 100grams can be given. 2. A dose of 20gram/day to 60gram/day in the following days.
Patients with Type 1 HRS will be given Terlipressin at the dose of 2mg/24 hrs as infusion. After 48 hours of initial monitoring, patients who do not respond to the initial dose of Terlipressin, will be randomised into group A and B. Group B patients will be treated with Terlipressin(2mg/24hr infusion- fixed dose) and Noradrenaline, which would be given as a continuous infusion at a starting dose of 0.5 mg/hr. The dose od noradrenaline will be increased every 24 hours in steps of 0.5 mg/hr, the maximum dose being 3 mg/hr IF: * the creatinine values decrease by \<12.5% * MAP increase of \<10 mmHg * urine output of \<200 ml in 4 hours.
Number of patients responding to treatment.
Complete response defined as serum creatinine \<1.5 mg/dl
Time frame: 15 days
Number of patients who will develop adverse events due to drugs used for treatment
Time frame: 15 days
Number of patients surviving without transplant.
Time frame: 90 days
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh