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PiCCO Guided Therapy in Liver Cirrhosis

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.
ClinicalTrials.gov Identifier: NCT00232427
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : October 3, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus intensified hemodynamic monitoring using the PiCCO system.

Condition or disease Intervention/treatment
Liver Cirrhosis Procedure: Hemodynamic monitoring system PiCCO

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : August 2005
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. Renal complications
  2. Length of intensive care
  3. Change in APACHE II

Eligibility Criteria

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 Posted: October 4, 2005    Key Record Dates
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