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Trial record 6 of 25 for:    terlipressin | Phase 3

TYPE 2 HEPATORENAL SYNDROME (Type2 HRS)

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ClinicalTrials.gov Identifier: NCT01637454
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
Arun Sharma, Postgraduate Institute of Medical Education and Research

Brief 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

Condition or disease Intervention/treatment Phase
Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS Drug: Noradrenaline Drug: Terlipressin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The primary end point of the study was serum creatinine less than 1.5 mg [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Secondary end points include death of patients [ Time Frame: 15 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637454


Locations
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India
Postgraduate Institute of Medical Education and Research Chandigarh
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Virendra Singh, DM Postgraduate Institute of Medical Education and Research, Chandigarh
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arun Sharma, Clinical Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01637454    
Other Study ID Numbers: PGIMERIndia
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by Arun Sharma, Postgraduate Institute of Medical Education and Research:
noradrenaline terlipressin type 2 HRS
Additional relevant MeSH terms:
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Terlipressin
Hepatorenal Syndrome
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Norepinephrine
Antihypertensive Agents
Vasoconstrictor Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents