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

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	November 2011
End Date:	August 2014

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.

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

We found this trial at

sites

Dr. Nate Shapiro

Boston, Massachusetts 02118

from

Boston, MA