Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT01062685
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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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02215, United States
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.
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:
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
Time frame: time 0 - 24 hrs
Time frame: In hospital
Beth Israel Deaconess Medical Center
Other
Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)
Acronym: St02
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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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