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TYPE 2 HEPATORENAL SYNDROME

Information source: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS

Intervention: Noradrenaline (Drug); Terlipressin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Postgraduate Institute of Medical Education and Research

Official(s) and/or principal investigator(s):
Virendra Singh, DM, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research Chandigarh

Summary

Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS

Clinical Details

Official title: NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary end point of the study was serum creatinine less than 1.5 mg

Secondary outcome: Secondary end points include death of patients

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Cirrhosis with ascites with serum creatinine more than 1. 5 mg/dl and less than 2. 5 mg/dl 2. Absence of shock, fluid losses and treatment with nephrotoxic drug 3. No improvement in renal function following diuretic withdrawal and plasma volume expansion 4. No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5. Absence of proteinuria more than 500 mg/24 hour Exclusion Criteria: 1. Patients with history of coronary artery disease 2. Cardiomyopathy 3. Ventricular arrhythmia

4. Obstructive arterial disease of limbs -

Locations and Contacts

Postgraduate Institute of Medical Education and Research Chandigarh, Chandigarh 160012, India
Additional Information

Starting date: January 2009
Last updated: July 10, 2012

Page last updated: August 23, 2015

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