An observational study in Shock, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Brigham and Women's Hospital · Observational
This pilot study aims to examine the relationship between continuously measured CareGuide™ 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 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.
916 studies on the registry are indexed under Shock; 176 are open to participants now.
This study's planned enrollment of 50 is below the median of 91 across 346 observational studies indexed under Shock.
Browse Shock studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Our study population is made up of adults admitted to an ICU with established or emerging shock.
Subjects who are:
Exclusion Criteria:
Subjects with:
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
Device: CareGuide™ device
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
Device: CareGuide™ device
CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
Peak systemic lactate
Cohort A
Time frame: Duration of monitoring (< 1 week)
Peak systemic lactate
Cohort B
Time frame: Duration of monitoring (< 1 week)
Temporal assessment of SmO2 and lactate
Time frame: Duration of monitoring (< 1 week)
Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)
Time frame: Duration of monitoring (< 1 week)
Systemic pH
Time frame: Duration of monitoring (< 1 week)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital