Clinical trial NCT00849641: Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis
Official title: Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Keywords: decompensation
septic shock
tissue oxygenation
near infrared spectroscopy
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with decompensated liver cirrhosis

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?

  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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital of Regensburg
Study officials:
affiliation: University of Regensburg
name: Sylvia Siebig, MD
role: PRINCIPAL_INVESTIGATOR
References: