TYPE 2 HEPATORENAL SYNDROME (Type2 HRS)
This study has been completed.
Sponsor:
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Arun Sharma, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01637454
First received: June 28, 2012
Last updated: July 10, 2012
Last verified: July 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS |
Drug: Noradrenaline Drug: Terlipressin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY |
Resource links provided by NLM:
Further study details as provided by Postgraduate Institute of Medical Education and Research:
Primary Outcome Measures:
- The primary end point of the study was serum creatinine less than 1.5 mg [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary end points include death of patients [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 46 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Terlipressin and Type-2 HRS
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour.
|
Drug: Noradrenaline
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
Drug: Terlipressin
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour
|
|
Active Comparator: Noradrenaline and Type-2 HRS
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
|
Drug: Noradrenaline
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
Drug: Terlipressin
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
- Absence of shock, fluid losses and treatment with nephrotoxic drug
- No improvement in renal function following diuretic withdrawal and plasma volume expansion
- No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour
Exclusion Criteria:
- Patients with history of coronary artery disease
- Cardiomyopathy
- Ventricular arrhythmia
- Obstructive arterial disease of limbs -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637454
Locations
| India | |
| Postgraduate Institute of Medical Education and Research Chandigarh | |
| Chandigarh, India, 160012 | |
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
| Principal Investigator: | Virendra Singh, DM | Postgraduate Institute of Medical Education and Research Chandigarh |
More Information
Publications:
| Responsible Party: | Arun Sharma, Clinical Professor, Postgraduate Institute of Medical Education and Research |
| ClinicalTrials.gov Identifier: | NCT01637454 History of Changes |
| Other Study ID Numbers: | PGIMERIndia |
| Study First Received: | June 28, 2012 |
| Last Updated: | July 10, 2012 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Postgraduate Institute of Medical Education and Research:
|
noradrenaline terlipressin type 2 HRS |
Additional relevant MeSH terms:
|
Hepatorenal Syndrome Liver Diseases Digestive System Diseases Kidney Diseases Urologic Diseases Norepinephrine Terlipressin Lypressin Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Antidiuretic Agents Natriuretic Agents Hemostatics Coagulants Hematologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013