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Near Infrared Spectroscopy (St02) (St02)

This study has been completed.
Sponsor:
Collaborators:
Hutchinson Technology Inc
Astute Medical, Inc.
Axis Shield Diagnostics Ltd
Information provided by (Responsible Party):
Nathan Shapiro, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01062685
First received: February 3, 2010
Last updated: April 25, 2017
Last verified: April 2017

February 3, 2010
April 25, 2017
January 2009
January 2010   (Final data collection date for primary outcome measure)
Organ Dysfunction and Severity of Illness [ Time Frame: time 0 - 24 hrs ]
Same as current
Complete list of historical versions of study NCT01062685 on ClinicalTrials.gov Archive Site
Mortality [ Time Frame: In hospital ]
Same as current
Not Provided
Not Provided
 
Near Infrared Spectroscopy (St02)
Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, serum
Non-Probability Sample
Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.
Septic Shock
Diagnostic Test: Near-infrared spectroscopy assessment

The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements.

Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes.

Other Name: NIRS assessment
  • Shock Cohort

    The SHOCK cohort will meet the American College of Chest physicians/Society of Critical Care Medicine criteria for septic shock, specifically:

    • 1) Suspected infection
    • 2) Any two of four criteria of systemic inflammatory response:

      • a. Temperature > 100.4° or < 96.8° F
      • b. Heart rate > 90 beats/minute
      • c. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
      • d. WBC >12,000 or < 4000 cells/µL or > 10% bands
    • 3) Hypotension despite adequate fluid resuscitation:

      • a. SBP < 90 mm Hg after 20cc/kg crystalloid
    Intervention: Diagnostic Test: Near-infrared spectroscopy assessment
  • Sepsis cohort

    The SEPSIS cohort will to meet:

    • 1) Suspected infection
    • 2) Any two of four criteria of systemic inflammatory response:

      • a. Temperature > 100.4° or < 96.8° F
      • b. Heart rate > 90 beats/minute
      • c. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
      • d. WBC >12,000 or < 4000 cells/µL or > 10% bands
    • 3) Absence of refractory hypotension
    Intervention: Diagnostic Test: Near-infrared spectroscopy assessment
  • Non-Infected controls
    The third cohort will be comprised of uninfected ED control patients who met the criteria of no suspected infection, no SIRS criteria met and no evidence of hypoperfusion that are age and sex matched on a 1:1 basis with the shock cohort.
    Intervention: Diagnostic Test: Near-infrared spectroscopy assessment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01062685
2008P000323
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Undecided
Not Provided
Nathan Shapiro, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • Hutchinson Technology Inc
  • Astute Medical, Inc.
  • Axis Shield Diagnostics Ltd
Principal Investigator: Nathan I Shapiro, MD, MPH Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP