NCT00232427

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 3, 2007

Status Verified

September 1, 2007

First QC Date

September 30, 2005

Last Update Submit

October 2, 2007

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosisHemodynamicsFluid balance

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (3)

  • Renal complications

  • Length of intensive care

  • Change in APACHE II

Interventions

Hemodynamic monitoring system PiCCOPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver cirrhosis Child-Pugh-Score \> 7
  • Ascites \> 500 ml

You may not qualify if:

  • Coronary heart disease
  • Apoplexia \< 6 months ago
  • Vasculitis
  • Thrombosis
  • Arterial occlusive disease \> stadium II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Clinical center

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Encke, PD Dr. med.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

August 1, 2005

Study Completion

August 1, 2007

Last Updated

October 3, 2007

Record last verified: 2007-09

Locations

DE(1)