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

February 3, 2010
February 3, 2010
September 2008
September 2010   (final data collection date for primary outcome measure)
Organ Dysfunction and Severity of Illness [ Time Frame: time 0 - 24 hrs ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Mortality [ Time Frame: In hospital ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Near Infrared Spectroscopy
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) 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum

Probability Sample

Emergency Department

Septic Shock
Not Provided
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
September 2010
September 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Nathan I Shapiro, MD, MPH` 617-754-2343 nshapiro@bidmc.harvard.edu
United States
 
NCT01062685
2008-000323
No
Nathan Shapiro, MD, MPH, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Hutchinson Technologies
Principal Investigator: Nathan I Shapiro, MD, MPH Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2010

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