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

Completed · Not applicable

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT01484106

Run by

Cheetah Medical Inc.

People needed

65

Starts

2011-11-01

Expected to finish

2014-08-01

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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