- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060369
BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
Study Overview
Detailed Description
Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A).
Noninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Subjects who are:
- To be admitted to the intensive care unit
- At least 18 years of age
- Men or Women
- Informed consent from subject or surrogate
- Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.
Exclusion Criteria:
Subjects with:
- Body mass index >37
- Trauma (primary diagnosis)
- Pregnancy
- Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome)
- Known untreated hypothyroidism
- Known hypersensitivity to medical adhesives
- Suspected carbon monoxide poisoning or methemoglobinemia
- Goals of care restricting vital sign acquisition
- Family member of investigators or study staff
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Established Shock (Cohort A)
Meeting criteria i or ii, AND iii: i. SBP ≤ 90mm Hg for greater than 30 minutes ii. Requirement for vasopressor or ionotrope to maintain SBP > 90mm Hg iii. New dysfunction of at least one organ, including altered mental status, acute renal failure (increase from baseline in serum creatinine >0.3 mg/dL or by 50%), oliguria (<0.5 mL/kg/h for >6h) , or hepatic injury (ALT, AST, or total bilirubin >2xULN)suspected by the treating physician to be caused by organ hypoperfusion |
CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
|
Emerging Shock (Cohort B)
Meeting criteria i or ii, AND iii: i. New SBP ≤ 90mm Hg for greater than 30 minutes or recurrent shorter episodes, requiring use of or clinical anticipation of the need for fluid resuscitation or vasopressor/inotropic support to maintain SBP > 90 mm Hg ii. New dysfunction of at least one organ (as defined above), including altered mental status, acute renal failure, oliguria, or hepatic injury not explained by a specific non-hemodynamic cause iii. Does not meet criteria for Established Shock |
CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak systemic lactate
Time Frame: Duration of monitoring (< 1 week)
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Cohort A
|
Duration of monitoring (< 1 week)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak systemic lactate
Time Frame: Duration of monitoring (< 1 week)
|
Cohort B
|
Duration of monitoring (< 1 week)
|
Temporal assessment of SmO2 and lactate
Time Frame: Duration of monitoring (< 1 week)
|
Duration of monitoring (< 1 week)
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Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)
Time Frame: Duration of monitoring (< 1 week)
|
Duration of monitoring (< 1 week)
|
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Systemic pH
Time Frame: Duration of monitoring (< 1 week)
|
Duration of monitoring (< 1 week)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BWH CareGuide
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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