Treatment of Hepatorenal Syndrome With Terlipressin Plus... | NCT00287664

Studies
Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

NCT00287664

Sponsor

Hospital Clinic of Barcelona

Status

Suspended

Last Update Posted

Apr 11, 2007Estimated

Enrollment

100

Phase

Phase 4

Conditions

Cirrhosis
Hepatorenal Syndrome

Interventions

terlipressin

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Feb 3, 2006

First Submission Date that Met QC Criteria

Feb 6, 2006

First Posted Date

Feb 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2007

Last Update Posted Date

Apr 11, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Collaborators

Name	Class
Grant from Education Ministery from 2001-2004.	UNKNOWN

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
terlipressin	Drug

Measure	Description	Time Frame
Survival

Eligibility Module

Eligibility Criteria

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 )

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pere Gines, MD	Chair of Liver Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic		Barcelona	Barcelona	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006530	Hepatorenal Syndrome

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077585	Terlipressin

Ancestor Terms

ID	Term
D008236	Lypressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided