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Completed

NCT Number: NCT01062685

Near Infrared Spectroscopy (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: NIRS assessment

Primary outcomes

  1. Organ Dysfunction and Severity of Illness

    Time frame: time 0 - 24 hrs

Secondary outcomes

  1. Mortality

    Time frame: In hospital

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Astute Medical, Inc.
  • Axis Shield Diagnostics Ltd
  • Hutchinson Technology Inc

Registry information

Official study title

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

Acronym: St02

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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