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

NCT01484106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-07-21

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Fluid Resuscitation

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).

OTHER

Standard of Care

Standard of Care

Sponsors & Collaborators

  • Cheetah Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Nate Shapiro, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484106 on ClinicalTrials.gov