CLEAR Sepsis Clinical Study (CLEAR Sepsis)

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).

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Device: ClearSight™ / EV1000NI Clinical Platform

• Study Type: Observational
• Enrollment (Anticipated): 182

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Recruiting
      • Ascension St. John Hospital
      • Contact: Claire Pearson, MD; Phone Number: 313-966-1829; Email: cpearson@med.wayne.edu
      • Contact: Thomas Mazzocco; Phone Number: 313-966-1829; Email: tmazzocc@med.wayne.edu
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Detroit Receiving Hospital
      • Contact: James Paxton, MD; Phone Number: 313-993-8464; Email: jpaxton@med.wayne.edu
      • Contact: Theodore Falcon; Phone Number: 313-993-8464; Email: tfalcon@med.wayne.edu
    • Detroit, Michigan, United States, 48235
      • Recruiting
      • Sinai-Grace Hospital
      • Contact: Robert Sherwin, MD; Phone Number: 313-966-9114; Email: rshewin@med.wayne.edu
      • Contact: Joshua Phillips; Phone Number: 313-966-9114; Email: jphillip@med.wayne.edu
    • Royal Oak, Michigan, United States, 48703
      • Terminated
      • Beaumont Hospital, Royal Oak
    • Troy, Michigan, United States, 48085
      • Terminated
      • Beaumont Hospital, Troy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Group 1; Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL	Device: ClearSight™ / EV1000NI Clinical Platform; Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Group 2; Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL	Device: ClearSight™ / EV1000NI Clinical Platform; Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Group 3; Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL	Device: ClearSight™ / EV1000NI Clinical Platform; Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2017-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes