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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Resuscitation

Other

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 care

Other

Standard of Care

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.

Sponsors and collaborators

Lead sponsor

Cheetah Medical Inc.

Industry

Registry information

Acronym: COMMIT

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Dec 2, 2011
Registry last updated: Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed