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Near Infrared Spectroscopy (St02)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hutchinson Technologies
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01062685
First received: February 3, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Septic Shock

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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • Mortality [ Time Frame: In hospital ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 300
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)
Groups/Cohorts
Septic Shock Cohort
Sepsis cohort
Pre-shock cohort
Non-Infected controls
Non-infected controls that are age and sex matched on a 1:1 basis with the septic shock cohort.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Emergency Department

Criteria

Inclusion Criteria:

There will be three cohorts enrolled in this study-

A. Septic Shock Cohort (n=60)

Inclusion criteria:

  1. Suspected infection

  2. Any two of four criteria of systemic inflammatory response:

    1. Temperature > 100.4° or < 96.8° F
    2. Heart rate > 90 beats/minute
    3. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
    4. WBC >12,000 or < 4000 cells/µL or > 10% bands

  3. Evidence of hypoperfusion evidenced by either of the following:

    1. SBP < 90 mm Hg after 20cc/kg crystalloid
    2. a whole blood lactate > 4 mmol/L
    3. vasopressor use

Exclusion criteria:

  1. Age < 18 years
  2. Pregnancy
  3. Acute traumatic or burn injury (primary diagnosis)
  4. Acute cerebrovascular event (primary diagnosis)
  5. Acute coronary syndrome (primary diagnosis)
  6. Acute pulmonary edema (primary diagnosis)
  7. Cardiac dysrhythmia (primary diagnosis)
  8. Acute and active gastrointestinal bleeding (primary diagnosis)
  9. Acute drug overdose (primary diagnosis)
  10. Requirement for immediate surgery

B. Sepsis Cohort (n=60)

Inclusion Criteria:

  1. Suspected infection

  2. Any two of four criteria of systemic inflammatory response:

    1. Temperature > 100.4° or < 96.8° F
    2. Heart rate > 90 beats/minute
    3. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
    4. WBC >12,000 or < 4000 cells/µL or > 10% bands

  3. NO Evidence of hypoperfusion evidenced by either of the following:

    1. SBP < 90 mm Hg after 20cc/kg crystalloid
    2. a whole blood lactate > 4 mmol/L

Exclusion Criteria: per above for septic shock cohort

C. Pre-Shock Cohort (n=60)

Inclusion Criteria:

  1. Suspected or confirmed infection as primary reason for admission
  2. Serum Lactate ≥2.0 and <4.0 mmol/L OR any SBP < 90 mmHg and now > 100mmHg
  3. Hospital admission planned
  4. Identification within 3 hours of lactate measurement or hypotension

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnancy

  3. Evidence of Overt Shock/Hypoperfusion upon enrollment:

    • Serum lactate ≥ 4.0 mmol/L
    • Any vasopressor or inotrope use
  4. Mechanical ventilation before enrollment
  5. Acute traumatic or burn injury
  6. Acute cerebrovascular event
  7. Acute coronary syndrome
  8. Acute pulmonary edema
  9. Acute and active gastrointestinal bleeding
  10. Requirement for immediate surgery
  11. Inability to obtain written informed consent
  12. Known reported stable systolic blood pressure < 100 mmHg
  13. Patient not eligible for vasopressor therapy (e.g. advanced directives)

D. Non-infected Controls (n=40)

Inclusion Criteria:

  1. No Suspected infection

  2. Absence of any systemic inflammatory response criteria:

    1. Temperature > 100.4° or < 96.8° F
    2. Heart rate > 90 beats/minute
    3. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
    4. WBC >12,000 or < 4000 cells/µL or > 10% bands

  3. NO Evidence of hypoperfusion evidenced by absence of either of the following:

    1. SBP < 90 mm Hg after 20cc/kg crystalloid
    2. a whole blood lactate > 4 mmol/L

Non-infected controls will be age and sex matched on a 1:1 basis with the septic shock cohort.

Exclusion Criteria: per above criteria for septic shock cohort

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

Contacts
Contact: Nathan I Shapiro, MD, MPH` 617-754-2343 nshapiro@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Nathan I Shapiro, MD, MPH            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Hutchinson Technologies
Investigators
Principal Investigator: Nathan I Shapiro, MD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nathan Shapiro, MD, MPH, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01062685     History of Changes
Other Study ID Numbers: 2008-000323
Study First Received: February 3, 2010
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013