Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT00849641|
Recruitment Status : Unknown
Verified February 2009 by University of Regensburg.
Recruitment status was: Not yet recruiting
First Posted : February 24, 2009
Last Update Posted : February 24, 2009
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Observational Model:||Case Control|
|Official Title:||Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||March 2011|
patients with decompensated liver cirrhosis admitted to the medical ICU
critically ill patients without liver cirrhosis, matched to group 1
healthy control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849641
|Contact: Sylvia Siebig, MD||+49 941 944 ext firstname.lastname@example.org|
|University Hospital of Regensburg||Not yet recruiting|
|Regensburg, Germany, 93042|
|Contact: Sylvia Siebig, MD +49 941 944 ext 7010 email@example.com|
|Contact: Christian E Wrede, MD +49 941 944 ext 7010 firstname.lastname@example.org|
|Principal Investigator:||Sylvia Siebig, MD||University of Regensburg|