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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
  Purpose
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.

Condition Intervention
Septic Shock Diagnostic Test: Near-infrared spectroscopy assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)

Resource links provided by NLM:


Further study details as provided by Nathan Shapiro, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Organ Dysfunction and Severity of Illness [ Time Frame: time 0 - 24 hrs ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: In hospital ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum

Enrollment: 186
Actual Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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
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
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.
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062685

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Hutchinson Technology Inc
Astute Medical, Inc.
Axis Shield Diagnostics Ltd
Investigators
Principal Investigator: Nathan I Shapiro, MD, MPH Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Nathan Shapiro, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01062685     History of Changes
Other Study ID Numbers: 2008P000323
Study First Received: February 3, 2010
Last Updated: April 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nathan Shapiro, Beth Israel Deaconess Medical Center:
septic shock
sepsis
St02
Near Infrared Spectroscopy
NIRS

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on September 19, 2017