The AVERT Sepsis Investigation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Christiana Care Health Services
Sponsor:
Collaborators:
Therapeutic Monitoring Systems
MaRS Discovery District, Government of Ontario
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01968746
First received: October 21, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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
Sepsis
Severe Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Progressive organ failure [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ED patients with suspected infection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted through the ED for suspected infection as primary reason for admission.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968746

Contacts
Contact: Ryan Arnold, MD (302) 733-4130 RyArnold@christianacare.org
Contact: Debra R Marco, RN (302)733-4130 DMarco@christianacare.org

Locations
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Jeffrey Sankoff, MD         
Principal Investigator: Jeffrey Sankoff, MD         
United States, Delaware
Christiana Health System Recruiting
Newark, Delaware, United States, 19718
Contact: Debra R. Marco, RN    302-733-4130    DMarco@christianacare.org   
Contact: Ryan Arnold, MD    302-733-4130    RyArnold@christianacare.org   
Principal Investigator: Christian Coletti, MD         
Sub-Investigator: Ryan Arnold, MD         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Randy Thompson, MD         
Principal Investigator: Randy Thompson, MD         
United States, New Jersey
Cooper University Hospital Completed
Camden, New Jersey, United States, 08103
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Sean Moore         
Contact: Geoff Green, MD         
Principal Investigator: Sean Moore, MD         
Sub-Investigator: Christophe Herry, PhD         
Sub-Investigator: Andrew JE Seely, MD PhD         
Sub-Investigator: Andrea Bravi         
Sponsors and Collaborators
Christiana Care Health Services
Therapeutic Monitoring Systems
MaRS Discovery District, Government of Ontario
Investigators
Principal Investigator: Ryan Arnold, MD Christiana Care Health Services
Study Chair: Andrew JE Seely, MD, PhD Ottawa Hospital
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01968746     History of Changes
Other Study ID Numbers: 602039
Study First Received: October 21, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Sepsis
Shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014