We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skeletal Muscle Oxygenation in Critically Ill

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00384644
Recruitment Status : Unknown
Verified June 2008 by University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : October 6, 2006
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
It is possible to measure skeletal muscle tissue oxygenation (StO2) using near infrared spectroscopy(NIRS). It is performed non invasively. We want to compare usually used invasive methods for assessing adequacy of flow to StO2 in critically ill. Aim is to faster and non invasively estimate adequacy of flow to make therapeutic algorithms efficient.

Condition or disease Intervention/treatment
Heart Failure Sepsis Septic Shock Cardiogenic Shock Device: NiRS measurment of tissue oxygenation

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skeletal Muscle Oxygenation in Critically Ill
Study Start Date : April 2004
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : December 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
1
sepsis, septic shock ptients
Device: NiRS measurment of tissue oxygenation
NiRS measurment of tissue oxygenation
2
cardiogenic shock patients
Device: NiRS measurment of tissue oxygenation
NiRS measurment of tissue oxygenation


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Intensive care patients
Criteria

Inclusion Criteria:

  • all typs of shock (cardiogenic, septic, hypovolemic, obstractive)

Exclusion Criteria:

  • patients/relatives refuse to participate in study
Contacts and Locations

Information from the National Library of Medicine

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): NCT00384644


Contacts
Contact: Matej Podbregar, MD PhD +386 40 215960 matej.podbegar@guest.arnes.si
Contact: Hugon Mozina, MD +386 41 779078 hugo.mozina@kclj.si

Locations
Slovenia
Clinical Center Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Matej Podbregar, MD PhD    +386 40 215960    matej.podbregar@guest.arnes.si   
Sub-Investigator: Hugon Mozina, MD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Principal Investigator: Matej Podbregar, MD PhD Medical Faculty, University of Ljubljana
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matej Podbregar, UMC Ljubljana
ClinicalTrials.gov Identifier: NCT00384644     History of Changes
Other Study ID Numbers: NIRS-1
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by University Medical Centre Ljubljana:
heart failure
sepsis
septic shock
cardiogenic shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Shock, Cardiogenic
Heart Failure
Sepsis
Critical Illness
Heart Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases