CLEAR Sepsis Clinical Study

NCT03231956 | Unknown FDA Device

• 1 other identifier: 2017-04
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 5

Brief 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, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).

Conditions

Sepsis

Outcome Measures

Primary Outcomes (4)

• Composite outcome

  Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.

  Within 72 hours of presentation

• Venous Blood Lactate clearance

  Venous Blood Lactate clearance

  Within 24 and 72 hours of presentation

• Length of Stay

  Emergency Department length of stay, ICU length of stay, and Hospital length of stay

  30 days

• Recidivism

  Recidivism within 30 days of the index hospital visit

  30 days

Study Arms (4)

Group 0

Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.

Device: ClearSight™ / EV1000NI Clinical Platform

Group 1

Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL

Device: ClearSight™ / EV1000NI Clinical Platform

Group 2

Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL

Device: ClearSight™ / EV1000NI Clinical Platform

Group 3

Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL

Device: ClearSight™ / EV1000NI Clinical Platform

Interventions

ClearSight™ / EV1000NI Clinical Platform DEVICE

Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System

Group 0; Group 1; Group 2; Group 3

Eligibility Criteria

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

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).

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• 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
• ≥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.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (5)

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

RECRUITING

Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

RECRUITING

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48703, United States

TERMINATED

Beaumont Hospital, Troy

Troy, Michigan, 48085, United States

TERMINATED

Biospecimen

Retention: SAMPLES WITH DNA

Laboratory specimens to be collected include blood and will be analyzed for lactate at a central clinical research laboratory (WSU Integrative Biosciences, Detroit, MI). Additionally, plasma samples will be obtained for and stored at the WSU Biobank to support potential future clinical and translational research. Samples for the purpose of the WSU Biobank are optional to the clinical research participant and will not adversely affect participation in the clinical trial.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jurandir Araujo, BA

CONTACT

949-250-5469; jurandir_araujo@edwards.com

Ryan Zafra, BS

CONTACT

949-250-1354; ryan_zafra@edwards.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 27, 2017
• Study Start: June 29, 2017
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)