Indocyangreen Elimination in Cirrhosis and Acute Liver Fa... | NCT00245310

Studies
Indocyangreen Elimination in Cirrhosis and Acute Liver Failure

NCT00245310

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Oct 11, 2010Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Acute Liver Failure
Liver Cirrhosis

Interventions

Indocyangreen (ICG) clearance

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Oct 25, 2005

First Submission Date that Met QC Criteria

Oct 25, 2005

First Posted Date

Oct 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2010

Last Update Posted Date

Oct 11, 2010Estimated

Description Module

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.

Detailed Description

patients with acute liver failure or advanced liver disease will be studied. ICG-clearance will be correlated with established clinical scores and outcome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Indocyangreen (ICG) clearance	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

portal vein thrombosis
allergy to ICG or iodine
thyroid disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Encke, PD Dr. med.	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19954554	Derived	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.

ID	Term
D017114	Liver Failure, Acute
D008103	Liver Cirrhosis

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases