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

Cheetah Medical Inc.65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sepsis

Interventions

Fluid ResuscitationOTHER

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 CareOTHER

Standard of Care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

University of Alabama

Birmingham, Alabama, United States

University of California

Sacramento, California, United States

Denver Health and Hospital Authority

Denver, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 72 hours

Data from ClinicalTrials.gov

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