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Sepsis | Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients

Sepsis research study

What is the primary objective of this study?

Hypotheses: 1. In the acute phase of early illness, tissue oxygen saturation and vascular occlusion test (VOT) are important adjuncts in differentiating severe critical illness requiring ICU admission from patients benefiting from less aggressive therapies (non-ICU admission). 2. An early feature of severe sepsis is abnormal microcirculatory vasoreactivity. 3. Microvascular reactivity can be measured by means of vascular occlusion test (VOT) using non-invasive near infrared spectroscopy (NIRS) to measure tissue Oxygen saturation (StO2). 4. Microvascular reactivity is significantly deranged in patients with early severe sepsis and is quantifiably different from non-septic critically ill patients. 5. Other measures of microcirculatory perfusion ie. sublingual orthogonal polarization spectral (OPS) video microscopy, are abnormal and will directionally correlate with VOT and StO2 in severe sepsis 6. In severely septic patients response to therapy can be assessed by VOT and StO2 monitoring and will correlate with prognosis. 7. A management protocol incorporating VOT and StO2 monitoring in addition to conventional hemodynamic and biochemical parameters as a guide to therapy will result in improved outcomes in severely septic patients. This project will investigate the use of a non-invasive near infrared light (NIR) device in conjunction with brief arm compression to measure the microcirculation in critically ill patients. It is know that in patients with overwhelming infections, their blood vessels do not respond normally and the NIR device can help measure how abnormal their blood vessels are. This type of testing is non-invasive and can be performed repeatedly without harm to the patient and may provide an earlier way to determine whether they have overwhelming sepsis and also may help to optimize the treatments they receive and better tailor their treatments to the degree of blood vessel abnormalities that are found. If our hypotheses are correct, this simple non-invasive test could provide a very rapid means of assessing patients that could be done more safely and quickly than some of the current methods. This would have an important effect to enhance patient safety and improve outcomes in such critically ill patients.

Who is eligible to participate?

Inclusion Criteria: - Adult patients undergoing assessment by critical care outreach team. Exclusion Criteria: - non-consent

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sepsis

Inflammation

Shock

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Early Sepsis Critically Ill PatientsPatients who are admitted to ICU with a diagnosis of early sepsis.

Non-septic Critically ill patientsPatients who are critically ill and admitted to ICU without diagnosis of sepsis.

Study Status

Suspended

Start Date: April 4, 2012

Completed Date: December 31, 2018

Phase:

Type: Observational

Design:

Primary Outcome: tNIRS Reperfusion slope of VOT

Secondary Outcome: tNIRS for Management of Critically Ill Patients with Sepsis

Study sponsors, principal investigator, and references

Principal Investigator: John Murkin, MD

Lead Sponsor: Lawson Health Research Institute

Collaborator: The Physicians' Services Incorporated Foundation

More information:https://clinicaltrials.gov/show/NCT01528358

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