Recruiting

Observational Study

Sponsor:

Edwards Lifesciences

Code:

NCT03231956

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ClearSight™ / EV1000NI Clinical Platform

Study Details

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

Study ID

NCT03231956

Start date

Jun 29, 2017

Status verified date

Mar, 2020

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

182 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 0

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

Group 1

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

Group 2

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

Group 3

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

Interventions

ClearSight™ / EV1000NI Clinical Platform

Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System

Primary outcome measure

  • Composite outcome [ Time Frame: Within 72 hours of presentation ]
  • Venous Blood Lactate clearance [ Time Frame: Within 24 and 72 hours of presentation ]
  • Length of Stay [ Time Frame: 30 days ]
  • Recidivism [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Jurandir Araujo, BA

949-250-5469jurandir_araujo@edwards.com

Ryan Zafra, BS

949-250-1354ryan_zafra@edwards.com

Locations

Detroit Receiving Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

James Paxton, MD

313-993-8464jpaxton@med.wayne.edu

Theodore Falcon

313-993-8464tfalcon@med.wayne.edu

Sinai-Grace Hospital

Recruiting

Detroit, Michigan, United States, 48235

Contacts

Robert Sherwin, MD

313-966-9114rshewin@med.wayne.edu

Joshua Phillips

313-966-9114jphillip@med.wayne.edu

Ascension St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Claire Pearson, MD

313-966-1829cpearson@med.wayne.edu

Thomas Mazzocco

313-966-1829tmazzocc@med.wayne.edu

More Information

Sponsor

Edwards Lifesciences

Last update posted

Mar 18, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Edwards Lifesciences on 2020-03-18.