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

Cheetah Medical

Status: Completed

Conditions: Sepsis

Treatments: Other: Standard of Care; Other: Fluid Resuscitation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484106

01-CM-2011

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Treatment group

Experimental group

Description:

Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms.

Treatment:

Other: Fluid Resuscitation

Control

Active Comparator group

Description:

Standard of Care

Treatment:

Other: Standard of Care