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

Cheetah Medical Inc.12 sites in 1 country65 target enrollmentNovember 2011

ConditionsSepsis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sepsis
Sponsor: Cheetah Medical Inc.
Enrollment: 65
Locations: 12
Primary Endpoint: sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

August 2014

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cheetah Medical Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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.

Time Frame: 72 hours

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.