NCT00287664

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

February 3, 2006

Last Update Submit

April 10, 2007

Conditions

CirrhosisHepatorenal Syndrome

Keywords

hepatorenal syndrometerlipressinalbumincirrhosis

Outcome Measures

Primary Outcomes (1)

  • Survival

Interventions

terlipressinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

FibrosisHepatorenal Syndrome

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Pere Gines, MD

    Chair of Liver Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 7, 2006

Study Start

February 1, 2002

Study Completion

September 1, 2006

Last Updated

April 11, 2007

Record last verified: 2007-04

Locations

ES(1)