ShockNCT03060369
BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
An observational study of Shock, run by Brigham and Women's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- CareGuide™ device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study population is made up of adults admitted to an ICU with established or emerging shock.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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).
Read the 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.
- Conditions
- Shock
- Being tested
- CareGuide™ device
- Keywords
- Tissue Perfusion, Noninvasive Monitoring, Near-infrared spectroscopy, CareGuide
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareGuide™ deviceDevice
CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: CareGuide™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak systemic lactate
Cohort A
Measured: Duration of monitoring (< 1 week)
Secondary outcomes (4)
Peak systemic lactate
Cohort B
Measured: Duration of monitoring (< 1 week)
Temporal assessment of SmO2 and lactate
Measured: Duration of monitoring (< 1 week)
Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)
Measured: Duration of monitoring (< 1 week)
Systemic pH
Measured: Duration of monitoring (< 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJun 2012
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Reflectance Medical, Inc.
- Responsible party
- Principal investigator, Stephen D. Wiviott, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060369
- Sponsor's protocol ID
- BWH CareGuide
- Status last verified
- Feb 2017
- First submitted
- 1 Aug 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
- ClinicalTrials.gov ID
- NCT03060369
- Acronym / sponsor ID
- BWH CareGuide
- Conditions
- Shock
- Keywords
- Tissue Perfusion, Noninvasive Monitoring, Near-infrared spectroscopy, CareGuide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Reflectance Medical, Inc.
- Study start
- Jun 2012 (actual)
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Established Shock (Cohort A) | – | Device: CareGuide™ deviceMeeting 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) | – | Device: CareGuide™ deviceMeeting 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population is made up of adults admitted to an ICU with established or emerging shock.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareGuide™ deviceCareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation. | Device | Emerging Shock (Cohort B), Established Shock (Cohort A) |
Primary outcome
Peak systemic lactate
Time frame: Duration of monitoring (< 1 week)
Cohort A
4 secondary outcomes
Peak systemic lactate
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak systemic lactate (time frame: Duration of monitoring (< 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.