Near Infrared Spectroscopy (St02)

Septic Shock Clinical Trial

— St02  

Official title:

Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062685
• Other study ID #: 2008P000323
• Status: Completed
• Phase: N/A
• First received: February 3, 2010
• Last updated: April 25, 2017
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Astute Medical, Inc., Axis Shield Diagnostics Ltd, Hutchinson Technology Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ Dysfunction and Severity of Illness		time 0 - 24 hrs
Secondary	Mortality		In hospital