PiCCO Guided Therapy in Liver Cirrhosis

October 2, 2007 updated by: Heidelberg University

Optimized Therapy of Decompensated Liver Cirrhosis by Hemodynamic Monitoring Using the PiCCO System

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Renal complications
Length of intensive care
Change in APACHE II

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Jens Encke, PD Dr. med., Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

October 3, 2007

Last Update Submitted That Met QC Criteria

October 2, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PiCCO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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