Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: Fluid Resuscitation; Other: Standard of Care

• Registration Number: NCT01484106
• Lead Sponsor: Cheetah Medical Inc.

Brief Summary

The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Adult patients > 18 years with old suspected or confirmed infection

2. At least two of the following four criteria (SIRS):

   1. Temperature > 38 or < 36o C
   2. Heart rate > 90 bpm
   3. Respiratory rate > 20 bpm or PaCO2< 32 mmHg
   4. White blood cell count >12,000 or <4,000 per mm3; or >10% bandemia

3. Lactate ≥2.0 and ≤4.0 mMol/L

4. Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria

Exclusion Criteria

1. Age < 18 years
2. On vasopressor therapy
3. Systolic blood pressure < 90 mmHg
4. Received more than 3-liter crystalloid fluid prior to randomization
5. Patient presenting with pulmonary edema
6. Patient presenting with acute coronary syndrome
7. Patient presenting with new onset cardiac arrhythmia
8. Patient presenting with trauma, including burns
9. Patient requires immediate surgery
10. Patient presenting with stroke
11. Patient with end stage renal disease on renal replacement therapy
12. Patient with known pregnancy
13. Patient being treated with immunosuppressive therapy for organ transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Fluid Resuscitation	Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms.
Control	Standard of Care	Standard of Care

Primary Outcome Measures

Name	Time	Method
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.	72 hours	A patient will be considered to have progressive organ dysfunction if their "Sequential Organ Failure Assessment" (SOFA) score increases by ≥1 point from their baseline score within 72 hours of study enrollment.

Trial Locations

Locations (12)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Humility of Mary Health Partners; 🇺🇸 Youngstown, Ohio, United States

Northwester University; 🇺🇸 Evanston, Illinois, United States

NY Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Dr. Nate Shapiro; 🇺🇸 Boston, Massachusetts, United States

The Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of California; 🇺🇸 Sacramento, California, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

MGH; 🇺🇸 Boston, Massachusetts, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States