Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients

This study is not yet open for participant recruitment.
Verified February 2012 by Lawson Health Research Institute
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
John Murkin, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01528358
First received: February 2, 2012
Last updated: February 8, 2012
Last verified: February 2012

February 2, 2012
February 8, 2012
February 2012
December 2015   (final data collection date for primary outcome measure)
tNIRS Reperfusion slope of VOT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01528358 on ClinicalTrials.gov Archive Site
tNIRS for Management of Critically Ill Patients with Sepsis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
In second phase of study patients critically ill with sepsis will be randomized to either use or non-use of tNIRS and VOT as a component of their clinical management. Number of survivors, length of ICU stay, SOFA and Apache scores on discharge from ICU will be compared between patients with either use or non-use of VOT-derived reperfusion slope which will be employed as a guide to monitor adequacy of tissue microcirculation and response to therapy.
tNIRS for Management of Critically Ill Patients with Sepsis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
In second phase of study patients critically ill with sepsis will be randomized to either use or non-use of tNIRS and VOT as a component of their clinical managment.
Not Provided
Not Provided
 
Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients
Tissue NIRS in the Assessment and Management of Critically Ill Patients

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.

Project Overview: This project is focused on the early diagnosis and management of septic shock using tissue near infrared spectroscopy (tNIRS) for continuous and non-invasive assessment of microcirculatory vasoreactivity as a diagnostic and prognostic indicator in critically ill patients. A novel aspect of this study is that point of entry of patients will be via the Critical Care Outreach Team (CCOT) which will ensure patients are assessed in the early phases of their disease prior to and co-incident with admission to Critical Care Unit (CCU). The investigators will employ tNIRS to assess peripheral tissue oxygen saturation (StO2) in all patients assessed by CCOT (n = 1031 patients in 2009) and in addition, the investigators will employ the NIRS vascular occlusion test (VOT) using a brief episode of forearm ischemia to quantify microvascular (dys)function.

All patients admitted to CCU via CCOT (n = 230 patients in 2009) will have StO2 monitored and VOT assessment sequentially throughout the course of their critical illness. Biomarkers to assess severity of illness, inflammatory processes and microcirculatory reactivity will be obtained, and in a subset of patients (n = 30), correlations between these parameters and other indices of microvascular perfusion using sublingual orthogonal polarization spectral (OPS) imaging videomicroscopy will be sought. As it is estimated that 20-30% of CCOT admissions are for sepsis (n = 40-60), the inclusion of other critically ill non-septic patients will enable discrimination of various parameters of VOT to be contrasted between groups to determine relative diagnostic and prognostic significance.

Statement of Objectives:

  1. To assess the diagnostic utility of tNIRS StO2 and VOT in early assessment of critically ill patients.
  2. To determine whether significant and pathognomonic differences exist in StO2 and indices of VOT between septic patients versus other non-septic critically ill patients and healthy age matched volunteers.
  3. To determine whether correlations exist between biomarkers of inflammation and vasoreactivity and measures of StO2 and VOT in severely septic patients.
  4. To determine whether incorporation of StO2 and VOT into a treatment protocol can positively impact clinical outcomes in critically ill patients.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood: inflammatory markers

Non-Probability Sample

Critically ill patients early in clinical course of illness.

  • Sepsis
  • Inflammation
  • Shock
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients undergoing assessment by critical care outreach team.

Exclusion Criteria:

  • non-consent
Both
18 Years to 90 Years
No
Contact: John m Murkin, MD 519-663-3384 john.murkin@lhsc.on.ca
Canada
 
NCT01528358
R11375
No
John Murkin, Lawson Health Research Institute
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Principal Investigator: John Murkin, MD University of Western Ontario, Canada
Lawson Health Research Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP