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Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Primary Purpose

Cirrhosis, Hepatorenal Syndrome

Status

Suspended

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

terlipressin

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring hepatorenal syndrome, terlipressin, albumin, cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL Age between 18 and 75 years Written informed consent. Absence of exclusion criteria Exclusion Criteria: Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm) Active infection with systemic inflammatory response syndrome Respiratory or cardiac dysfunction. Arteriopathy. Ischemic cardiopathy. Arterial hypertension ( >140/90 mmHg during hospitalization )

Sites / Locations

Hospital Clinic

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00287664

First Posted

February 3, 2006

Last Updated

April 10, 2007

Sponsor

Hospital Clinic of Barcelona

Collaborators

Grant from Education Ministery from 2001-2004.

1. Study Identification

Unique Protocol Identification Number

NCT00287664

Brief Title

Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Official Title

Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Suspended

Why Stopped

because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.

Study Start Date

February 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Clinic of Barcelona

Collaborators

Grant from Education Ministery from 2001-2004.

4. Oversight

5. Study Description

Brief Summary

Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

Detailed Description

Phase 3

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Hepatorenal Syndrome

Keywords

hepatorenal syndrome, terlipressin, albumin, cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

terlipressin

Primary Outcome Measure Information:

Title

Survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pere Gines, MD

Organizational Affiliation

Chair of Liver Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

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