Near Infrared Spectroscopy (St02)

NCT01062685 | Completed

• 1 other identifier: 2008P000323
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock

Keywords

septic shock; sepsis; St02; Near Infrared Spectroscopy; NIRS

Outcome Measures

Primary Outcomes (1)

• Organ Dysfunction and Severity of Illness

  time 0 - 24 hrs

Secondary Outcomes (1)

• Mortality

  In hospital

Study Arms (3)

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

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

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

Interventions

Near-infrared spectroscopy assessment DIAGNOSTIC_TEST

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.

Also known as: NIRS assessment

Non-Infected controls; Sepsis cohort; Shock Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.

You may qualify if:

• Listed on the Cohorts description.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Hutchinson Technology Inc: collaborator
• Astute Medical, Inc.: collaborator
• Axis Shield Diagnostics Ltd: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Skibsted S, Arnold R, Sherwin R, Singh S, Lundy D, Nelson T, Puskarich MA, Trzeciak S, Jones AE, Shapiro NI. The association of near infrared spectroscopy-derived StO2 measurements and biomarkers of endothelial activation in sepsis. Intern Emerg Med. 2013 Sep;8(6):529-36. doi: 10.1007/s11739-013-0973-3. Epub 2013 Jul 4.

  PMID: 23824446 RESULT

• 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.

  PMID: 21939529 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Nathan I Shapiro, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)