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The AVERT Sepsis Investigation (AVERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01968746
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : July 11, 2016
Therapeutic Monitoring Systems
MaRS Discovery District
Information provided by (Responsible Party):
Christiana Care Health Services

Brief Summary:

The overall objective of this study is to utilize heart rate variability and respiratory rate variability in patients with sepsis to predict clinical deterioration and death.

Our specific objectives are:

  1. To study the ability of a change in composite variability (∆CVI) assessment to act as a prognostic aid in predicting disease progression in sepsis.
  2. To study the effect that standard resuscitation interventions will have on the direction and magnitude of ∆CVI in patients with sepsis.

B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter composite variability index (CVI) over 4 hours will predict a significant increase in the combined outcome of overt shock, organ dysfunction, and mortality.

H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over 4 hours will be associated with a low or declining CVI.

Condition or disease
Sepsis Severe Sepsis

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis
Study Start Date : August 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

ED patients with suspected infection

Primary Outcome Measures :
  1. Progressive organ failure [ Time Frame: 72 hours ]
    A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted through the ED for suspected infection as primary reason for admission.

Inclusion Criteria:

  • 1. Antibiotics ordered or administered (as surrogate for suspected or confirmed infection as primary reason for hospital admission as determined by the primary team) 2. Serum lactate ≥ 2.0 mmol/L or transient hypotension (any systolic blood pressure < 100 mmHg).

    3. Identification within 12 hours of a qualifying lactate measurement or hypotension episode 4. Hospital admission planned for suspected infection as primary reasons for admission (per emergency medicine team).

Exclusion Criteria:

  • 1. Age < 18 years 2. Pregnancy 3. Non-sinus cardiac rhythm (atrial fibrillation, active pacemaker, SVT) 4. Evidence of Overt Shock upon enrollment:

    • Hypotension: SBP < 90 mmHg for ≥ 60 minutes
    • Any vasopressor or inotrope use (e.g. norepinephrine, dopamine, vasopressin, dobutamine) 5. Acute respiratory support (BiPAP or mechanical ventilation) before enrollment 6. Inability to obtain written informed consent from patient or legally authorized representative 7. Inability to wear Zephyr Bioharness device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01968746

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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Delaware
Christiana Health System
Newark, Delaware, United States, 19718
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
Christiana Care Health Services
Therapeutic Monitoring Systems
MaRS Discovery District
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Principal Investigator: Ryan Arnold, MD Christiana Care Health Services
Study Chair: Andrew JE Seely, MD, PhD Ottawa Hospital
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Responsible Party: Christiana Care Health Services Identifier: NCT01968746    
Other Study ID Numbers: 602039
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by Christiana Care Health Services:
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes