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PiCCO Guided Therapy in Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hemodynamic monitoring system PiCCO
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cirrhosis focused on measuring Liver cirrhosis, Hemodynamics, Fluid balance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Heidelberg, Clinical center

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Renal complications
Length of intensive care
Change in APACHE II

Full Information

First Posted
September 30, 2005
Last Updated
October 2, 2007
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00232427
Brief Title
PiCCO Guided Therapy in Liver Cirrhosis
Official Title
Optimized Therapy of Decompensated Liver Cirrhosis by Hemodynamic Monitoring Using the PiCCO System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Liver cirrhosis, Hemodynamics, Fluid balance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hemodynamic monitoring system PiCCO
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
Renal complications
Title
Length of intensive care
Title
Change in APACHE II

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Encke, PD Dr. med.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg, Clinical center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

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PiCCO Guided Therapy in Liver Cirrhosis

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