Critically IllGreenpepNCT01126554
ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill Patients
An observational study of Critically Ill, run by University of Zurich at 1 site in Switzerland.
Trial summary
Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critically Ill
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Feb 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients of a 10 bed ICU unit
Who may be able to join
- All patients admitted to the ICU
Who cannot join
- Not able to understand German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill
Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients.
Read the detailed description
Comparison of different marker for length of stay in the ICU in critically ill patients.
- Conditions
- Critically Ill
- Keywords
- Prognostic value
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prolonged length of stay in the ICU (pLOS) more than 3 days
see above
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionFeb 2011
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 Critically IllStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Brahms AG
- Responsible party
- Sponsor
- Investigators
- Markus Béchir, MD, Principal investigator, CIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126554
- Sponsor's protocol ID
- CIM_MB 002
- Other IDs
- CIM_02
- Acronym
- Greenpep
- Status last verified
- Apr 2014
- First submitted
- 17 May 2010
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zoller B, Spanaus K, Gerster R, Fasshauer M, Stehberger PA, Klinzing S, Vergopoulos A, von Eckardstein A, Bechir M. ICG-liver test versus new biomarkers as prognostic markers for prolonged length of stay in critically ill patients - a prospective study of accuracy for prediction of length of stay in the ICU. Ann Intensive Care. 2014 Jul 8;4:19. doi: 10.1186/s13613-014-0019-7. eCollection 2014.
PubMed 25045579
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill
- ClinicalTrials.gov ID
- NCT01126554
- Acronym / sponsor ID
- Greenpep / CIM_MB 002
- Conditions
- Critically Ill
- Keywords
- Prognostic value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Brahms AG
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 May 2010 (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.
Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients.
Detailed description
Comparison of different marker for length of stay in the ICU in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients of a 10 bed ICU unit
Key inclusion criteria (1 listed)
- All patients admitted to the ICU
Key exclusion criteria (1 listed)
- Not able to understand German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prolonged length of stay in the ICU (pLOS) more than 3 days
Time frame: 3 days
see above
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 29 Apr 2014.
- Derived from this study: PubMed 25045579Zoller B, Spanaus K, Gerster R, Fasshauer M, Stehberger PA, Klinzing S, Vergopoulos A, von Eckardstein A, Bechir M. ICG-liver test versus new biomarkers as prognostic markers for prolonged length of stay in critically ill patients - a prospective study of accuracy for prediction of length of stay in the ICU. Ann Intensive Care. 2014 Jul 8;4:19. doi: 10.1186/s13613-014-0019-7. eCollection 2014.
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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.
Markus Béchir, MD principal investigator
CIM
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 Critically Ill, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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 29 Apr 2014. 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 Switzerland. 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.
What does the primary outcome measure?
prolonged length of stay in the ICU (pLOS) more than 3 days (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126554, 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 29 Apr 2014.