Acute Liver FailureNCT00245310
Indocyangreen Elimination in Cirrhosis and Acute Liver Failure
An observational study of Acute Liver Failure and Liver Cirrhosis, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Liver Failure, Liver Cirrhosis
- What is being tested?
- Indocyangreen (ICG) clearance
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute liver failure OR end-stage liver disease
- normal hepatic perfusion by doppler ultrasound
Who cannot join
- portal vein thrombosis
- allergy to ICG or iodine
- thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Indocyangreen Elimination as a Prognostic Marker in Decompensated Cirrhosis and Acute Liver Failure
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.
Read the 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.
- Conditions
- Acute Liver Failure, Liver Cirrhosis
- Being tested
- Indocyangreen (ICG) clearance
- Keywords
- ICG clearance, liver cirrhosis, acute liver failure, prognosis
- Medical subject headings
- Liver Failure, Acute, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyangreen (ICG) clearanceProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Jens Encke, PD Dr. med., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245310
- Sponsor's protocol ID
- LiMON
- Status last verified
- Nov 2008
- First submitted
- 25 Oct 2005
- Last updated
- 11 Oct 2010
- Results posted
- No
Publications
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.
PubMed 19954554
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Indocyangreen Elimination as a Prognostic Marker in Decompensated Cirrhosis and Acute Liver Failure
- ClinicalTrials.gov ID
- NCT00245310
- Acronym / sponsor ID
- LiMON
- Conditions
- Acute Liver Failure, Liver Cirrhosis
- Keywords
- ICG clearance, liver cirrhosis, acute liver failure, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute liver failure OR end-stage liver disease
- normal hepatic perfusion by doppler ultrasound
Key exclusion criteria (3 listed)
- portal vein thrombosis
- allergy to ICG or iodine
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyangreen (ICG) clearance | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2010.
- Derived from this study: PubMed 19954554Merle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Encke, PD Dr. med. principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure and Liver Cirrhosis, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00245310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2010.