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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Other: Fluid Resuscitation
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the Treatment or Standard Care arms. | Other: Fluid Resuscitation<br>* 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).<br>|
| Active Comparator: Control<br>Standard of Care | Other: Standard of Care<br>* Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |