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Clinical Trials/NCT01062685
NCT01062685
Completed
Not Applicable

Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)

Beth Israel Deaconess Medical Center1 site in 1 country186 target enrollmentJanuary 2009
ConditionsSeptic Shock

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
186
Locations
1
Primary Endpoint
Organ Dysfunction and Severity of Illness
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

Near-infrared spectroscopy (NIRS) noninvasively measures peripheral tissue oxygen saturation (StO2), offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving. There are three main NIRS measurements reported in the literature: continuous StO2 measurement (StO2 initial), StO2 occlusion slope (StO2 downslope) in response to VOT testing and StO2 recovery slope (StO2 upslope) in response to vasoocclusive testing. The purpose of this study is to assesses the association of each of these parameters with severity of illness, organ dysfunction and death. 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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
January 2010
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nathan Shapiro

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • Listed on the Cohorts description.

Exclusion Criteria

  • All patient cohorts will share common set of exclusion criteria:
  • Age \< 18 years
  • Pregnancy
  • Established "Do Not Resuscitate" orders prior to enrollment
  • Primary diagnosis of:
  • Acute traumatic or burn injury
  • Acute cerebrovascular event
  • Acute coronary syndrome
  • Acute pulmonary edema
  • Cardiac dysrhythmia

Outcomes

Primary Outcomes

Organ Dysfunction and Severity of Illness

Time Frame: time 0 - 24 hrs

Secondary Outcomes

  • Mortality(In hospital)

Study Sites (1)

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