PiCCO Guided Therapy in Liver Cirrhosis

This study has been completed.

First Received on September 30, 2005. Last Updated on October 2, 2007 History of Changes

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00232427

Purpose

Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus intensified hemodynamic monitoring using the PiCCO system.

Condition	Intervention
Liver Cirrhosis	Procedure: Hemodynamic monitoring system PiCCO

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Optimized Therapy of Decompensated Liver Cirrhosis by Hemodynamic Monitoring Using the PiCCO System

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Survival

Secondary Outcome Measures:

Renal complications
Length of intensive care
Change in APACHE II

Enrollment:	20
Study Start Date:	August 2005
Study Completion Date:	August 2007

Detailed Description:

Patients presenting with advanced liver cirrhosis will receive either standard treatment or standard treatment plus hemodynamic monitoring with the PiCCO device. Fluids and vasoacitve drugs will be administered according to the measurements over a period of 5 days.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Liver cirrhosis Child-Pugh-Score > 7
Ascites > 500 ml

Exclusion Criteria:

Coronary heart disease
Apoplexia < 6 months ago
Vasculitis
Thrombosis
Arterial occlusive disease > stadium II

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232427

Locations

Germany
University of Heidelberg, Clinical center
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Jens Encke, PD Dr. med.

University of Heidelberg

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00232427 History of Changes
Other Study ID Numbers:	PiCCO
Study First Received:	September 30, 2005
Last Updated:	October 2, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

Liver cirrhosis
Hemodynamics
Fluid balance

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012