Status:
COMPLETED
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Lead Sponsor:
Cheetah Medical Inc.
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01484106
Start Date
November 1 2011
End Date
August 1 2014
Last Update
July 21 2021
Active Locations (12)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California
Sacramento, California, United States, 95817
3
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
4
Northwester University
Evanston, Illinois, United States, 60208