SepsisNCT01528358
Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients
An observational study of Sepsis and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Inflammation, Shock
- How many people
- 672 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2012to 12 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients early in clinical course of illness.
Who may be able to join
- Adult patients undergoing assessment by critical care outreach team.
Who cannot join
- non-consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Hospital, London Health Sciences Center
London, Ontario, N5A 5A5
About this study
Official title: Tissue NIRS in the Assessment and Management of Critically Ill Patients
Hypotheses:
- 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).
- An early feature of severe sepsis is abnormal microcirculatory vasoreactivity.
- 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).
- Microvascular reactivity is significantly deranged in patients with early severe sepsis and is quantifiably different from non-septic critically ill patients.
- 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
- In severely septic patients response to therapy can be assessed by VOT and StO2 monitoring and will correlate with prognosis.
- 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.
Read the detailed description
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:
- To assess the diagnostic utility of tNIRS StO2 and VOT in early assessment of critically ill patients.
- 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.
- To determine whether correlations exist between biomarkers of inflammation and vasoreactivity and measures of StO2 and VOT in severely septic patients.
- To determine whether incorporation of StO2 and VOT into a treatment protocol can positively impact clinical outcomes in critically ill patients.
- Conditions
- Sepsis, Inflammation, Shock
- Keywords
- sepsis, tissue oximetry, NIRS, VOT
- Medical subject headings
- Sepsis, Inflammation, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
tNIRS for Management of Critically Ill Patients with Sepsis
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study start4 Apr 2012
- Primary completion31 Dec 2017
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, John Murkin, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- John Murkin, MD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528358
- Sponsor's protocol ID
- R11375
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2012
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue NIRS in the Assessment and Management of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01528358
- Acronym / sponsor ID
- R11375
- Conditions
- Sepsis, Inflammation, Shock
- Keywords
- sepsis, tissue oximetry, NIRS, VOT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 4 Apr 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotheses:
- 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).
- An early feature of severe sepsis is abnormal microcirculatory vasoreactivity.
- 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).
- Microvascular reactivity is significantly deranged in patients with early severe sepsis and is quantifiably different from non-septic critically ill patients.
- 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
- In severely septic patients response to therapy can be assessed by VOT and StO2 monitoring and will correlate with prognosis.
- 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.
Detailed description
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:
- To assess the diagnostic utility of tNIRS StO2 and VOT in early assessment of critically ill patients.
- 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.
- To determine whether correlations exist between biomarkers of inflammation and vasoreactivity and measures of StO2 and VOT in severely septic patients.
- To determine whether incorporation of StO2 and VOT into a treatment protocol can positively impact clinical outcomes in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients early in clinical course of illness.
Key inclusion criteria (1 listed)
- Adult patients undergoing assessment by critical care outreach team.
Key exclusion criteria (1 listed)
- non-consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tNIRS Reperfusion slope of VOT
Time frame: 12 months
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.
1 secondary outcome
tNIRS for Management of Critically Ill Patients with Sepsis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Murkin, MD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tNIRS Reperfusion slope of VOT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.