Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Phase 3

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhosis Hepatorenal Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

terlipressin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with HRS type 1 or 2 with serum creatinine \>2 mg/dL
2. Age between 18 and 75 years
3. Written informed consent.

Exclusion Criteria

1. Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule \> than 5 cm)
2. Active infection with systemic inflammatory response syndrome
3. Respiratory or cardiac dysfunction.
4. Arteriopathy.
5. Ischemic cardiopathy.
6. Arterial hypertension ( \>140/90 mmHg during hospitalization )

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pere Gines, MD

Role: PRINCIPAL_INVESTIGATOR

Chair of Liver Unit

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAHRS

Identifier Type: -

Identifier Source: org_study_id