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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: Fluid Resuscitation; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • Sacramento, California, United States, 95817
      • University of California
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwester University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH
    • Boston, Massachusetts, United States, 02115
      • The Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Dr. Nate Shapiro
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Brooklyn, New York, United States, 11215
      • NY Methodist Hospital
  • Ohio
    • Youngstown, Ohio, United States, 98661
      • Humility of Mary Health Partners
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms.	Other: Fluid Resuscitation; In the Treatment group, this information will be used in a specific 4-hour treatment algorithm to guide fluid administration that is summarized in Figure 1. The information provided by the NICOM in response to the fluid bolus will be used to assess whether the subject is "fluid responsive" (FR).
Active Comparator: Control; Standard of Care	Other: Standard of Care; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.	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.	72 hours

Collaborators and Investigators

• Sponsor: Cheetah Medical Inc.
• Investigators: Principal Investigator: Nate Shapiro, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: 01-CM-2011