Clinical trial NCT01062685: Near Infrared Spectroscopy (St02)
Official title: Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: septic shock
sepsis
St02
Near Infrared Spectroscopy
NIRS
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Hutchinson Technology Inc
name: Astute Medical, Inc.
name: Axis Shield Diagnostics Ltd
First posted: 2010-02-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.

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.

Eligibility criteria: There will be three cohorts enrolled in this study: (1) Septic Shock, (2) Sepsis and (3) Controls.

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
  * Acute and active gastrointestinal bleeding
  * Acute drug overdose
  * Requirement for immediate surgery
  * Inability to obtain written informed consent

Primary outcomes:
measure: Organ Dysfunction and Severity of Illness
timeFrame: time 0 - 24 hrs
Secondary outcomes:
measure: Mortality
timeFrame: In hospital
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Nathan I Shapiro, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skibsted S, Arnold R, Sherwin R, Singh S, Lundy D, Nelson T, Puskarich MA, Trzeciak S, Jones AE, Shapiro NI. The association of near infrared spectroscopy-derived StO2 measurements and biomarkers of endothelial activation in sepsis. Intern Emerg Med. 2013 Sep;8(6):529-36. doi: 10.1007/s11739-013-0973-3. Epub 2013 Jul 4.
citation: Shapiro NI, Arnold R, Sherwin R, O'Connor J, Najarro G, Singh S, Lundy D, Nelson T, Trzeciak SW, Jones AE; Emergency Medicine Shock Research Network (EMShockNet). The association of near-infrared spectroscopy-derived tissue oxygenation measurements with sepsis syndromes, organ dysfunction and mortality in emergency department patients with sepsis. Crit Care. 2011;15(5):R223. doi: 10.1186/cc10463. Epub 2011 Sep 22.