Liver CirrhosisNCT00849641
Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis
An observational study of Liver Cirrhosis, run by University of Regensburg at 1 site in Germany.
Trial summary
Patients with decompensated liver cirrhosis exhibit numerous hemodynamic and microvascular changes, i.e., low systemic blood pressure and peripheral vasodilatation. In addition, alterations of tissue oxygenation are described in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with decompensated liver cirrhosis
Who may be able to join
- patients with decompensated liver cirrhosis admitted to the medical ICU
- written informed consent signed by the patients or his/her closest family member
- age ≥ 18year
Who cannot join
- no written informed consent signed by the patients or his/her closest family member
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Regensburg
Regensburg, 93042
Sylvia Siebig, MD, +49 941 944 ext. 7010, sylvia.siebig@klinik.uni-regensburg.de
Christian E Wrede, MD, +49 941 944 ext. 7010, christian.wrede@klinik.uni-regensburg.de
About this study
Patients with decompensated liver cirrhosis exhibit numerous hemodynamic and microvascular changes, i.e., low systemic blood pressure and peripheral vasodilatation. In addition, alterations of tissue oxygenation are described in these patients.
Near-infrared spectroscopy (NIRS) has been proposed as a tool to quantify microvascular dysfunction, for example in patients with sepsis (1) or after trauma (2). NIRS is a non-invasive technique that uses the differential absorption properties of oxygenated and desoxygenated hemoglobin to evaluate skeletal muscle oxygenation (3).
Read more
Up to the investigators' knowledge no data exist on NIRS measurements in patients with decompensated liver cirrhosis.
Aims of this study are to evaluate:
- Are there any changes in NIRS parameters in patients with decompensated liver cirrhosis in comparison to other critically ill patients (matched to SAPS II Score) or healthy individuals?
- Is there a correlation with common accepted prognostic scores (MELD Score or indocyanin green clearance) in decompensated liver cirrhosis patients and initial NIRS parameters?
- Does the NIRS trend within the first three days of ICU care in decompensated liver cirrhosis patients receiving fluid replacement therapy correlate with the course of disease?
- De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104.
- Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008 Jun;14(3):361-6.
- Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56.
Read the detailed description
Patients fulfilling inclusion criteria and without exclusion criteria will be monitored by NIRS using InSpectra™ technology (Hutchinson, USA) for the first three days of their ICU hospitalization. Besides registration of the NIRS parameters (tissue hemoglobin saturation (StO2), total tissue hemoglobin (THI), dynamic test values by using occlusion testing) baseline characteristics (age, sex, SAPS II Score et.), disease relevant information (etiology of liver cirrhosis, cause of ICU hospitalization) and ICU data (catecholamine therapy, mechanical ventilation, hemodynamic monitoring, fluid therapy) will be recorded. Within the observation time, an indocyanin green-clearance measurement and further laboratory testing will be performed on a daily basis. Data will be pseudonymized and kept confidential according to the guidelines of the local ethics committee.
- Conditions
- Liver Cirrhosis
- Keywords
- decompensation, septic shock, tissue oxygenation, near infrared spectroscopy
- Medical subject headings
- Liver Cirrhosis, Shock, Septic
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 |
|---|---|---|
| 1 | patients with decompensated liver cirrhosis admitted to the medical ICU | |
| 2 | critically ill patients without liver cirrhosis, matched to group 1 | |
| 3 | healthy control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Investigators
- Sylvia Siebig, MD, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849641
- Sponsor's protocol ID
- UR-ST9201/09
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT00849641
- Acronym / sponsor ID
- UR-ST9201/09
- Conditions
- Liver Cirrhosis
- Keywords
- decompensation, septic shock, tissue oxygenation, near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 24 Feb 2009 (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.
Patients with decompensated liver cirrhosis exhibit numerous hemodynamic and microvascular changes, i.e., low systemic blood pressure and peripheral vasodilatation. In addition, alterations of tissue oxygenation are described in these patients.
Near-infrared spectroscopy (NIRS) has been proposed as a tool to quantify microvascular dysfunction, for example in patients with sepsis (1) or after trauma (2). NIRS is a non-invasive technique that uses the differential absorption properties of oxygenated and desoxygenated hemoglobin to evaluate skeletal muscle oxygenation (3).
Up to the investigators' knowledge no data exist on NIRS measurements in patients with decompensated liver cirrhosis.
Aims of this study are to evaluate:
- Are there any changes in NIRS parameters in patients with decompensated liver cirrhosis in comparison to other critically ill patients (matched to SAPS II Score) or healthy individuals?
- Is there a correlation with common accepted prognostic scores (MELD Score or indocyanin green clearance) in decompensated liver cirrhosis patients and initial NIRS parameters?
- Does the NIRS trend within the first three days of ICU care in decompensated liver cirrhosis patients receiving fluid replacement therapy correlate with the course of disease?
- De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104.
- Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008 Jun;14(3):361-6.
- Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56.
Detailed description
Patients fulfilling inclusion criteria and without exclusion criteria will be monitored by NIRS using InSpectra™ technology (Hutchinson, USA) for the first three days of their ICU hospitalization. Besides registration of the NIRS parameters (tissue hemoglobin saturation (StO2), total tissue hemoglobin (THI), dynamic test values by using occlusion testing) baseline characteristics (age, sex, SAPS II Score et.), disease relevant information (etiology of liver cirrhosis, cause of ICU hospitalization) and ICU data (catecholamine therapy, mechanical ventilation, hemodynamic monitoring, fluid therapy) will be recorded. Within the observation time, an indocyanin green-clearance measurement and further laboratory testing will be performed on a daily basis. Data will be pseudonymized and kept confidential according to the guidelines of the local ethics committee.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with decompensated liver cirrhosis admitted to the medical ICU |
| 2 | – | –critically ill patients without liver cirrhosis, matched to group 1 |
| 3 | – | –healthy control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with decompensated liver cirrhosis
Key inclusion criteria (3 listed)
- patients with decompensated liver cirrhosis admitted to the medical ICU
- written informed consent signed by the patients or his/her closest family member
- age ≥ 18year
Key exclusion criteria (1 listed)
- no written informed consent signed by the patients or his/her closest family member
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
Sylvia Siebig, MD principal investigator
University of Regensburg
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 Liver Cirrhosis, run by University of Regensburg 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 3 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Siebig, MD (+49 941 944 ext. 7010, sylvia.siebig@klinik.uni-regensburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 24 Feb 2009.