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Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Regensburg.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00849641
First received: February 20, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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?

    1. 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.
    2. Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008 Jun;14(3):361-6.
    3. 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
Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by University of Regensburg:

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with decompensated liver cirrhosis

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • no written informed consent signed by the patients or his/her closest family member
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849641

Contacts
Contact: Sylvia Siebig, MD +49 941 944 ext 7010 sylvia.siebig@klinik.uni-regensburg.de

Locations
Germany
University Hospital of Regensburg Not yet recruiting
Regensburg, Germany, 93042
Contact: Sylvia Siebig, MD     +49 941 944 ext 7010     sylvia.siebig@klinik.uni-regensburg.de    
Contact: Christian E Wrede, MD     +49 941 944 ext 7010     christian.wrede@klinik.uni-regensburg.de    
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Sylvia Siebig, MD University of Regensburg
  More Information

No publications provided

Responsible Party: Dr. Sylvia Siebig, MD, University of Regensburg, Germany
ClinicalTrials.gov Identifier: NCT00849641     History of Changes
Other Study ID Numbers: UR-ST9201/09
Study First Received: February 20, 2009
Last Updated: February 20, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
decompensation
septic shock
tissue oxygenation
near infrared spectroscopy

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013