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

NCT03060369 | Unknown

• 1 other identifier: BWH CareGuide
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Shock

Keywords

Tissue Perfusion; Noninvasive Monitoring; Near-infrared spectroscopy; CareGuide

Outcome Measures

Primary Outcomes (1)

• Peak systemic lactate

  Cohort A

  Duration of monitoring (< 1 week)

Secondary Outcomes (4)

• Peak systemic lactate

  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)

• Systemic pH

  Duration of monitoring (< 1 week)

Study Arms (2)

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

Device: CareGuide™ device

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

Device: CareGuide™ device

Interventions

CareGuide™ device DEVICE

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

Emerging Shock (Cohort B); Established Shock (Cohort A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study population is made up of adults admitted to an ICU with established or emerging shock.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Reflectance Medical, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: February 23, 2017
• Study Start: June 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)