NCT00245310

Brief Summary

Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and liver perfusion. The ICG-clearance will be evaluated as a prognostic marker in liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

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

October 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 11, 2010

Status Verified

November 1, 2008

Enrollment Period

5 years

First QC Date

October 25, 2005

Last Update Submit

October 8, 2010

Conditions

Acute Liver FailureLiver Cirrhosis

Keywords

ICG clearanceliver cirrhosisacute liver failureprognosis

Interventions

Indocyangreen (ICG) clearancePROCEDURE

Eligibility Criteria

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

You may qualify if:

  • acute liver failure OR end-stage liver disease
  • normal hepatic perfusion by doppler ultrasound

You may not qualify if:

  • portal vein thrombosis
  • allergy to ICG or iodine
  • thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • Merle U, Sieg O, Stremmel W, Encke J, Eisenbach C. Sensitivity and specificity of plasma disappearance rate of indocyanine green as a prognostic indicator in acute liver failure. BMC Gastroenterol. 2009 Dec 3;9:91. doi: 10.1186/1471-230X-9-91.

    PMID: 19954554DERIVED

MeSH Terms

Conditions

Liver Failure, AcuteLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Encke, PD Dr. med.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 11, 2010

Record last verified: 2008-11

Locations

DE(1)