Near Infrared Spectroscopy (St02)
Recruitment status was Recruiting
The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)|
- Organ Dysfunction and Severity of Illness [ Time Frame: time 0 - 24 hrs ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: In hospital ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||September 2010|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Septic Shock Cohort|
Non-infected controls that are age and sex matched on a 1:1 basis with the septic shock cohort.
Near Infrared Spectroscopy (NIRS) can be utilized to measure tissue oxygenation, offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving. Three distinct ways to measure StO2 have been proposed: 1) initial random spot-check measurements (StO2 initial); 2) minimum value over a 3-hour observation period (StO2 min); and, 3) changes in StO2 in response to an ischemic challenge (change in StO2 and StO2 slope). The purpose of this study is to assess the diagnostic ability of each of these parameters to predict morbidity, mortality, and resource utilization.
This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062685
|Contact: Nathan I Shapiro, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: Nathan I Shapiro, MD, MPH|
|Principal Investigator:||Nathan I Shapiro, MD, MPH||Beth Israel Deaconess Medical Center|