NCT00384644

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

4.8 years

First QC Date

October 4, 2006

Last Update Submit

June 4, 2008

Conditions

Keywords

heart failuresepsisseptic shockcardiogenic shock

Study Arms (2)

1

sepsis, septic shock ptients

Device: NiRS measurment of tissue oxygenation

2

cardiogenic shock patients

Device: NiRS measurment of tissue oxygenation

Interventions

NiRS measurment of tissue oxygenation

12

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care patients

You may qualify if:

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

You may not qualify if:

  • patients/relatives refuse to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Center Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (3)

  • Pareznik R, Knezevic R, Voga G, Podbregar M. Changes in muscle tissue oxygenation during stagnant ischemia in septic patients. Intensive Care Med. 2006 Jan;32(1):87-92. doi: 10.1007/s00134-005-2841-8. Epub 2005 Nov 1.

    PMID: 16261341BACKGROUND
  • Mozina H, Podbregar M. Near-infrared spectroscopy during stagnant ischemia estimates central venous oxygen saturation and mixed venous oxygen saturation discrepancy in patients with severe left heart failure and additional sepsis/septic shock. Crit Care. 2010;14(2):R42. doi: 10.1186/cc8929. Epub 2010 Mar 23.

  • Podbregar M, Mozina H. Skeletal muscle oxygen saturation does not estimate mixed venous oxygen saturation in patients with severe left heart failure and additional severe sepsis or septic shock. Crit Care. 2007;11(1):R6. doi: 10.1186/cc5153.

MeSH Terms

Conditions

Heart FailureSepsisShock, SepticShock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockMyocardial InfarctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Matej Podbregar, MD PhD

    Medical Faculty, University of Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matej Podbregar, MD PhD

CONTACT

Hugon Mozina, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

April 1, 2004

Primary Completion

January 1, 2009

Study Completion

December 1, 2010

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations