Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis

NCT00849641 | Unknown

• 1 other identifier: UR-ST9201/09
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Cirrhosis

Keywords

decompensation; septic shock; tissue oxygenation; near infrared spectroscopy

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with decompensated liver cirrhosis

You may qualify if:

• 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

You may not qualify if:

• no written informed consent signed by the patients or his/her closest family member

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

University Hospital of Regensburg

Regensburg, 93042, Germany

Location

MeSH Terms

Conditions

Liver Cirrhosis; Shock, Septic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Study Officials

• Sylvia Siebig, MD

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia Siebig, MD

CONTACT

+49 941 944; sylvia.siebig@klinik.uni-regensburg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

DE (1)