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

NCT01484106 | Completed

• 1 other identifier: 01-CM-2011
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 12

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.

  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.

  72 hours

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms.

Other: Fluid Resuscitation

Control

ACTIVE COMPARATOR

Standard of Care

Other: Standard of Care

Interventions

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).

Treatment group

Standard of Care OTHER

Standard of Care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cheetah Medical Inc.: lead

Study Sites (12)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California

Sacramento, California, 95817, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Northwester University

Evanston, Illinois, 60208, United States

Location

MGH

Boston, Massachusetts, 02114, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dr. Nate Shapiro

Boston, Massachusetts, 02118, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

NY Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Humility of Mary Health Partners

Youngstown, Ohio, 98661, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nate Shapiro, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (12)