SepsisCLEAR SepsisNCT03231956
CLEAR Sepsis Clinical Study
An observational study of Sepsis, run by Edwards Lifesciences at 5 sites in United States.
Trial summary
To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- ClearSight™ / EV1000NI Clinical Platform
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jun 2017to 30 Jun 2022
- 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: Patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).
Who may be able to join
- ≥ 18 years of age at the time of enrollment
- Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
- ED Physician confirms likely hospital admission (> 50%) due to suspicion of infection
- ED Physician confirms intention to order both blood cultures and venous blood lactate levels
- Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation
- ≥18 years of age at the time of enrollment
- Presents to the ED with a chief complaint consistent with a minor infection (upper respiratory infection, soft tissue infection, viral infection) or an asthma or COPD exacerbation on whom the treating physician is not ordering labs for blood cultures or lactate levels
- Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation.
Who cannot join
- Initial venous blood lactate measured > 3 hours after ED arrival
- Pre-existing infection for which patient is being treated with antibiotics as an outpatient
- Prisoners
- Pregnant women
- Any previous medical condition with life expectancy of < 3 months (patients with ESRD and heart failure are not excluded)
- DNR or comfort care order preexisting to ED visit or established in the ED
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- Palliative care or hospice consult in the ED
- Known severe aortic insufficiency
- Known history of Raynaud's disease
- Poor follow-up candidate in the opinion of the Investigator
- Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
- Control Sepsis Mimic
- Pre-existing infection for which patient is being treated with antibiotics as an outpatient
- Prisoners
- Pregnant women
- Any previous medical condition with life expectancy of < 3 months (patients with ESRD and heart failure are not excluded)
- DNR or comfort care order preexisting to ED visit or established in the ED
- Palliative care or hospice consult in the ED
- Known severe aortic insufficiency
- Known history of Raynaud's disease
- Poor follow-up candidate in the opinion of the Investigator
- Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
- Treating physician is planning on ordering either a lactate or blood cultures on the patient.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 3 recruiting
- Recruiting
Detroit Receiving Hospital
Detroit, Michigan, 48201
James Paxton, MD, 313-993-8464, jpaxton@med.wayne.edu
Theodore Falcon, 313-993-8464, tfalcon@med.wayne.edu
- Recruiting
Sinai-Grace Hospital
Detroit, Michigan, 48235
Robert Sherwin, MD, 313-966-9114, rshewin@med.wayne.edu
Joshua Phillips, 313-966-9114, jphillip@med.wayne.edu
- Recruiting
Ascension St. John Hospital
Detroit, Michigan, 48236
Claire Pearson, MD, 313-966-1829, cpearson@med.wayne.edu
Thomas Mazzocco, 313-966-1829, tmazzocc@med.wayne.edu
- Terminated
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48703
- Terminated
Beaumont Hospital, Troy
Troy, Michigan, 48085
About this study
Official title: Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).
- Conditions
- Sepsis
- Being tested
- ClearSight™ / EV1000NI Clinical Platform
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearSight™ / EV1000NI Clinical PlatformDevice
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
| Study group | Role | What they receive |
|---|---|---|
| Group 0 | Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup. Receives: Device: ClearSight™ / EV1000NI Clinical Platform | |
| Group 1 | Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL Receives: Device: ClearSight™ / EV1000NI Clinical Platform | |
| Group 2 | Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL Receives: Device: ClearSight™ / EV1000NI Clinical Platform | |
| Group 3 | Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL Receives: Device: ClearSight™ / EV1000NI Clinical Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.
Measured: Within 72 hours of presentation
Venous Blood Lactate clearance
Venous Blood Lactate clearance
Measured: Within 24 and 72 hours of presentation
Length of Stay
Emergency Department length of stay, ICU length of stay, and Hospital length of stay
Measured: 30 days
Recidivism
Recidivism within 30 days of the index hospital visit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start29 Jun 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231956
- Sponsor's protocol ID
- 2017-04
- Acronym
- CLEAR Sepsis
- Status last verified
- Mar 2020
- First submitted
- 21 Jul 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
- ClinicalTrials.gov ID
- NCT03231956
- Acronym / sponsor ID
- CLEAR Sepsis / 2017-04
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Jul 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.
To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 0 | – | Device: ClearSight™ / EV1000NI Clinical PlatformControl Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup. |
| Group 1 | – | Device: ClearSight™ / EV1000NI Clinical PlatformSuspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL |
| Group 2 | – | Device: ClearSight™ / EV1000NI Clinical PlatformSuspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL |
| Group 3 | – | Device: ClearSight™ / EV1000NI Clinical PlatformSuspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).
Key inclusion criteria (8 listed)
- ≥ 18 years of age at the time of enrollment
- Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
- ED Physician confirms likely hospital admission (> 50%) due to suspicion of infection
- ED Physician confirms intention to order both blood cultures and venous blood lactate levels
- Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation
Key exclusion criteria (23 listed)
- Initial venous blood lactate measured > 3 hours after ED arrival
- Pre-existing infection for which patient is being treated with antibiotics as an outpatient
- Prisoners
- Pregnant women
- Any previous medical condition with life expectancy of < 3 months (patients with ESRD and heart failure are not excluded)
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 |
|---|---|---|
| ClearSight™ / EV1000NI Clinical PlatformNoninvasive Hemodynamic Monitoring utilizing ClearSight TM System | Device | Group 0, Group 1, Group 2, Group 3 |
Primary outcome
Composite outcome
Time frame: Within 72 hours of presentation
Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.
Venous Blood Lactate clearance
Time frame: Within 24 and 72 hours of presentation
Venous Blood Lactate clearance
Length of Stay
Time frame: 30 days
Emergency Department length of stay, ICU length of stay, and Hospital length of stay
Recidivism
Time frame: 30 days
Recidivism within 30 days of the index hospital visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Edwards Lifesciences at 5 sites 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 8 inclusion and 23 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Jurandir Araujo, BA (949-250-5469, jurandir_araujo@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: Within 72 hours of presentation). The study lists 4 primary outcomes in all. 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 18 Mar 2020.