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NCT00232427 Clinical Trial

PiCCO Guided Therapy in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00232427
Other study ID # PiCCO
Secondary ID
Status Completed
Phase N/A
First received September 30, 2005
Last updated October 2, 2007
Start date August 2005
Est. completion date August 2007

Study information
Verified date September 2007
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Hemodynamic monitoring system PiCCO

Locations
Country Name City State
Germany University of Heidelberg, Clinical center Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival
Secondary Renal complications
Secondary Length of intensive care
Secondary Change in APACHE II
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