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

This study has suspended participant recruitment.
(Study was halted and will be used as a pilot study.)
Sponsor:
Information provided by (Responsible Party):
Cheetah Medical Inc.
ClinicalTrials.gov Identifier:
NCT01484106
First received: November 28, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention
Sepsis
Other: Fluid Resuscitation
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Cheetah Medical Inc.:

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. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: November 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484106

Locations
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
Dr. Nate Shapiro
Boston, Massachusetts, United States, 02118
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
MGH
Boston, Massachusetts, United States, 02114
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.
Investigators
Principal Investigator: Nate Shapiro, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Cheetah Medical Inc.
ClinicalTrials.gov Identifier: NCT01484106     History of Changes
Other Study ID Numbers: 01-CM-2011
Study First Received: November 28, 2011
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Emergencies
Sepsis
Toxemia
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 29, 2014