Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients
| Tracking Information | |||||
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| First Received Date ICMJE | February 2, 2012 | ||||
| Last Updated Date | February 8, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01528358 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
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. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Tissue Near InfraRed Spectroscopy (NIRS) in Critically Ill Patients | ||||
| Official Title ICMJE | Tissue NIRS in the Assessment and Management of Critically Ill Patients | ||||
| Brief Summary | Hypotheses:
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. |
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| 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:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Blood: inflammatory markers |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Critically ill patients early in clinical course of illness. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01528358 | ||||
| Other Study ID Numbers ICMJE | R11375 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | John Murkin, Lawson Health Research Institute | ||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||
| Collaborators ICMJE | The Physicians' Services Incorporated Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Lawson Health Research Institute | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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