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| Name | Class |
|---|---|
| Reflectance Medical, Inc. | UNKNOWN |
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This pilot study aims to examine the relationship between continuously measured CareGuideâ„¢ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).
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 CareGuideâ„¢ 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 CareGuideâ„¢ monitoring period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareGuideâ„¢ device | Device | CareGuideâ„¢ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak systemic lactate | Cohort A | Duration of monitoring (< 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak systemic lactate | Cohort B | Duration of monitoring (< 1 week) |
| Temporal assessment of SmO2 and lactate | Duration of monitoring (< 1 week) |
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Inclusion Criteria:
Subjects who are:
Exclusion Criteria:
Subjects with:
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Our study population is made up of adults admitted to an ICU with established or emerging shock.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive) | Duration of monitoring (< 1 week) |
| Systemic pH | Duration of monitoring (< 1 week) |