CLEAR SepsisNoninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Data Collection
Collected from today forward - ProspectiveInfections+3
+ Inflammation
+ Pathologic Processes
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.182 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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
Sinai-Grace Hospital
Detroit, United StatesAscension St. John Hospital
Detroit, United StatesBeaumont Hospital, Royal Oak
Royal Oak, United States