PiCCO Guided Therapy in Liver Cirrhosis

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00232427
First received: September 30, 2005
Last updated: October 2, 2007
Last verified: September 2007
  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:


Further study details as provided by Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
University of Heidelberg, Clinical center
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Jens Encke, PD Dr. med. Heidelberg University
  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 Heidelberg University:
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 July 22, 2014