Suspended

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

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Infections+3

+ Inflammation

+ Pathologic Processes

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: June 2017
See protocol details

Summary

Principal SponsorEdwards Lifesciences
Study ContactJurandir Araujo, BAMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 29, 2017

Actual date on which the first participant was enrolled.

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).

Official TitleNoninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Principal SponsorEdwards Lifesciences
Study ContactJurandir Araujo, BAMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

182 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsis

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Detroit Receiving Hospital

Detroit, United StatesOpen Detroit Receiving Hospital in Google Maps
Recruiting

Sinai-Grace Hospital

Detroit, United States
Recruiting

Ascension St. John Hospital

Detroit, United States
Suspended

Beaumont Hospital, Royal Oak

Royal Oak, United States
Suspended5 Study Centers