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


ABSTRACT: 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.Prospective, 10-center, randomized interventional trial.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.fluid responsiveness protocol using Non-Invasive Cardiac Output Monitor (NICOM) to assess for fluid responsiveness (>10% increase in stroke volume in response to 5?mL/kg fluid bolus) with balance of a liter given in responsive patients.standard clinical care.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.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?>?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]: 786-1,314) vs. 1,031?mL (95% CI: 741-1,325) (P?=?0.93); however, treatment patients received more fluids during the protocol (2,633?mL [95% CI: 2,264-3,001] vs. 1,002?mL [95% CI: 707-1,298]) (P?

SUBMITTER: Hou PC 

PROVIDER: S-EPMC4957967 | BioStudies | 2016-01-01

REPOSITORIES: biostudies

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