BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock

• Conditions: Shock
• Interventions: Device: CareGuide™ device

• Registration Number: NCT03060369
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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).

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-08-01
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Subjects who are:

1. To be admitted to the intensive care unit
2. At least 18 years of age
3. Men or Women
4. Informed consent from subject or surrogate
5. Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.

Exclusion Criteria

Subjects with:

1. Body mass index >37
2. Trauma (primary diagnosis)
3. Pregnancy
4. Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome)
5. Known untreated hypothyroidism
6. Known hypersensitivity to medical adhesives
7. Suspected carbon monoxide poisoning or methemoglobinemia
8. Goals of care restricting vital sign acquisition
9. Family member of investigators or study staff

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Established Shock (Cohort A)	CareGuide™ device	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
Emerging Shock (Cohort B)	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

Primary Outcome Measures

Name	Time	Method
Peak systemic lactate	Duration of monitoring (< 1 week)	Cohort A

Secondary Outcome Measures

Name	Time	Method
Peak systemic lactate	Duration of monitoring (< 1 week)	Cohort B
Systemic pH	Duration of monitoring (< 1 week)
Temporal assessment of SmO2 and lactate	Duration of monitoring (< 1 week)
Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)	Duration of monitoring (< 1 week)

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States