Near Infrared Spectroscopy (St02)

Beth Israel Lahey Health

Status: Completed

Conditions: Septic Shock

Treatments: Diagnostic Test: Near-infrared spectroscopy assessment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01062685

2008P000323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

186 participants in 3 patient groups

Shock Cohort

Description:

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

Treatment:

Diagnostic Test: Near-infrared spectroscopy assessment

Sepsis cohort

Description:

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

Treatment:

Diagnostic Test: Near-infrared spectroscopy assessment

Non-Infected controls

Description:

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.

Treatment:

Diagnostic Test: Near-infrared spectroscopy assessment