Clinical trial NCT01484106: Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Official title: Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Sacramento
country: United States
facility: University of California
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Evanston
country: United States
facility: Northwester University
state: Illinois
city: Boston
country: United States
facility: MGH
state: Massachusetts
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dr. Nate Shapiro
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: NY Methodist Hospital
state: New York
city: Youngstown
country: United States
facility: Humility of Mary Health Partners
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Nate Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: