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

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03060369
• Other study ID #: BWH CareGuide
• Status: Active, not recruiting
• Phase: N/A
• First received: August 1, 2013
• Last updated: February 21, 2017
• Start date: June 2012
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

Device:
• CareGuide™ device
CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Reflectance Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak systemic lactate	Cohort A	Duration of monitoring (< 1 week)
Secondary	Peak systemic lactate	Cohort B	Duration of monitoring (< 1 week)
Secondary	Temporal assessment of SmO2 and lactate		Duration of monitoring (< 1 week)
Secondary	Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)		Duration of monitoring (< 1 week)
Secondary	Systemic pH		Duration of monitoring (< 1 week)