Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Patients with Sepsis.

Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Patients with Sepsis.

Hou Peter C; Filbin Michael R; Napoli Anthony; Feldman Joseph; Pang Peter S; Sankoff Jeffrey; Lo Bruce M; Dickey-White Howard; Birkhahn Robert H; Shapiro Nathan I

Shock (Augusta, Ga.)

2016

2016-08

OBJECTIVE: Fluid responsiveness is proposed as a physiology-based method to titrate fluid therapy based on preload dependence. The objectives of this study were to determine if a fluid responsiveness protocol would decrease progression of organ dysfunction, and a fluid responsiveness protocol would facilitate a more aggressive resuscitation. METHODS: Prospective, 10-center, randomized interventional trial. INCLUSION CRITERIA: suspected sepsis and lactate 2.0 to 4.0 mmol/L. Exclusion criteria (abbreviated): systolic blood pressure more than 90 mmHg, and contraindication to aggressive fluid resuscitation. INTERVENTION: fluid responsiveness protocol using Non-Invasive Cardiac Output Monitor (NICOM) to assess for fluid responsiveness (\textgreater10% increase in stroke volume in response to 5 mL/kg fluid bolus) with balance of a liter given in responsive patients. CONTROL: standard clinical care. OUTCOMES: primary-change in Sepsis-related Organ Failure Assessment (SOFA) score at least 1 over 72 h; secondary-fluids administered. Trial was initially powered at 600 patients, but stopped early due to a change in sponsor's funding priorities. RESULTS: Sixty-four patients were enrolled with 32 in the treatment arm. There were no significant differences between arms in age, comorbidities, baseline vital signs, or SOFA scores (P \textgreater 0.05 for all). Comparing treatment versus Standard of Care-there was no difference in proportion of increase in SOFA score of at least 1 point (30% vs. 33%) (note bene underpowered, P = 1.0) or mean preprotocol fluids 1,050 mL (95% confidence interval [CI]:

Adult; Aged; Cardiac Output/*physiology; Emergency Service; Female; Fluid Therapy/*methods; Hospital/*statistics & numerical data; Humans; Lactic Acid/therapeutic use; Male; Middle Aged; Monitoring; Multicenter Studies as Topic; Physiologic/methods; Prospective Studies; Sepsis/*physiopathology/*therapy; Septic/physiopathology/therapy; Shock; Stroke Volume/physiology

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