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PiCCO Guided Therapy in Liver Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232427
First Posted: October 4, 2005
Last Update Posted: October 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00232427     History of Changes
Other Study ID Numbers: PiCCO
First Submitted: September 30, 2005
First Posted: October 4, 2005
Last Update Posted: October 3, 2007
Last Verified: September 2007

Keywords provided by Heidelberg University:
Liver cirrhosis
Hemodynamics
Fluid balance

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases