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

Sepsis Clinical Trial

— COMMIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484106
• Other study ID #: 01-CM-2011
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: August 2014

Study information

• Verified date: July 2021
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

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).
• Standard of Care
Standard of Care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cheetah Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.	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.	72 hours