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

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid Resuscitation
Standard of Care
Sponsored by
Cheetah Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • University of California
  • Denver Health and Hospital Authority
  • Northwester University
  • MGH
  • The Brigham and Women's Hospital
  • Dr. Nate Shapiro
  • Hackensack University Medical Center
  • NY Methodist Hospital
  • Humility of Mary Health Partners
  • Rhode Island Hospital
  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control

Arm Description

Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms.

Standard of Care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2011
Last Updated
July 19, 2021
Sponsor
Cheetah Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01484106
Brief Title
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Acronym
COMMIT
Official Title
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cheetah Medical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard of Care
Intervention Type
Other
Intervention Name(s)
Fluid Resuscitation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients > 18 years with old suspected or confirmed infection At least two of the following four criteria (SIRS): Temperature > 38 or < 36o C Heart rate > 90 bpm Respiratory rate > 20 bpm or PaCO2< 32 mmHg White blood cell count >12,000 or <4,000 per mm3; or >10% bandemia Lactate ≥2.0 and ≤4.0 mMol/L Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria Exclusion Criteria: Age < 18 years On vasopressor therapy Systolic blood pressure < 90 mmHg Received more than 3-liter crystalloid fluid prior to randomization Patient presenting with pulmonary edema Patient presenting with acute coronary syndrome Patient presenting with new onset cardiac arrhythmia Patient presenting with trauma, including burns Patient requires immediate surgery Patient presenting with stroke Patient with end stage renal disease on renal replacement therapy Patient with known pregnancy Patient being treated with immunosuppressive therapy for organ transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nate Shapiro, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Northwester University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dr. Nate Shapiro
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NY Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Humility of Mary Health Partners
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
98661
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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

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