Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients

NCT01528358 | Completed

• 1 other identifier: R11375
• Study Type: observational
• Target: 672
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotheses:

1. 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. 2.An early feature of severe sepsis is abnormal microcirculatory vasoreactivity.
3. 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. 4.Microvascular reactivity is significantly deranged in patients with early severe sepsis and is quantifiably different from non-septic critically ill patients.
5. 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. 6.In severely septic patients response to therapy can be assessed by VOT and StO2 monitoring and will correlate with prognosis.
7. 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.

Conditions

Sepsis; Inflammation; Shock

Keywords

sepsis; tissue oximetry; NIRS; VOT

Outcome Measures

Primary Outcomes (1)

• tNIRS Reperfusion slope of VOT

  Sequential mesures of tNIRS VOT will be performed in septic and non-septic patients early in thier clinical course and reperfusion slope of VOT will be contrasted between these patient groups.

  12 months

Secondary Outcomes (1)

• tNIRS for Management of Critically Ill Patients with Sepsis

  12 months

Study Arms (2)

Early Sepsis Critically Ill Patients

Patients who are admitted to ICU with a diagnosis of early sepsis.

Non-septic Critically ill patients

Patients who are critically ill and admitted to ICU without diagnosis of sepsis.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients early in clinical course of illness.

You may qualify if:

• Adult patients undergoing assessment by critical care outreach team.

You may not qualify if:

• non-consent

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

University Hospital, London Health Sciences Center

London, Ontario, N5A 5A5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood: inflammatory markers

MeSH Terms

Conditions

Sepsis; Inflammation; Shock

Condition Hierarchy (Ancestors)

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

Study Officials

• John Murkin, MD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 8, 2012
• Study Start: April 4, 2012
• Primary Completion: December 31, 2017
• Study Completion: August 12, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CA (1)