CLEAR Sepsis Clinical Study

Sepsis Clinical Trial

— CLEAR Sepsis  

Official title:

Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231956
• Other study ID #: 2017-04
• Status: Recruiting
• Start date: June 29, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2020
• Source: Edwards Lifesciences
• Contact: Jurandir Araujo, BA
• Phone: 949-250-5469
• Email: jurandir_araujo[@]edwards.com
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Venous Blood Lactate Groups

Inclusion Criteria:

• = 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• =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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Device:
• ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System

Locations

Country	Name	City	State
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Sinai-Grace Hospital	Detroit	Michigan
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan
United States	Beaumont Hospital, Troy	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome	Increase in modified Sequential Organ Failure Assessment (mSOFA) score = 1 resulting in ICU admission / death.	Within 72 hours of presentation
Primary	Venous Blood Lactate clearance	Venous Blood Lactate clearance	Within 24 and 72 hours of presentation
Primary	Length of Stay	Emergency Department length of stay, ICU length of stay, and Hospital length of stay	30 days
Primary	Recidivism	Recidivism within 30 days of the index hospital visit	30 days