Renal and Cardiovascular Effects of Terlipressin in Patie... | NCT00115947

Studies
Renal and Cardiovascular Effects of Terlipressin in Patients With Cirrhosis and Ascites

NCT00115947

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Mar 9, 2006Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Cirrhosis
Ascites

Interventions

Terlipressin

Countries

Denmark

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

Jun 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Jun 26, 2005

First Submission Date that Met QC Criteria

Jun 26, 2005

First Posted Date

Jun 27, 2005Estimated

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

Mar 8, 2006

Last Update Posted Date

Mar 9, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to investigate the effect of terlipressin on myocardial perfusion and renal function.

Hypothesis: Significant improvement of renal function reflected by: glomerular filtration rate (GFR), renal blood flow (RBF), excretion of salt and metabolites in the urine and related hormones and peptides in the blood. No effect on the systolic function of the heart.

Detailed Description

Not provided

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Terlipressin	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhosis and ascites

Accepts Healthy Volunteers

Not provided

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
Aleksander Krag Krag, MD	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital		Copenhagen	Hvidovre	2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D001201	Ascites

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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