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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484106
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sepsis Other: Fluid Resuscitation Other: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Study Start Date : November 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01484106

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

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Responsible Party: Cheetah Medical Inc. Identifier: NCT01484106     History of Changes
Other Study ID Numbers: 01-CM-2011
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: September 2012
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome