The AVERT Sepsis Investigation

NCT01968746 | Completed

• 1 other identifier: 602039
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 5

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. 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. 2.To study the effect that standard resuscitation interventions will have on the direction and magnitude of ∆CVI in patients with sepsis.

Conditions

Sepsis; Severe Sepsis

Keywords

Sepsis; Shock

Outcome Measures

Primary Outcomes (1)

• Progressive organ failure

  A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)

  72 hours

Study Arms (1)

ED patients with suspected infection

Eligibility Criteria

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

Study Population

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

You may qualify if:

• \. 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).
• \. 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).

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Therapeutic Monitoring Systems: collaborator
• MaRS Discovery District: collaborator

Study Sites (5)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Christiana Health System

Newark, Delaware, 19718, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Sepsis; Shock

Condition Hierarchy (Ancestors)

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

Study Officials

• Ryan Arnold, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

• Andrew JE Seely, MD, PhD

  Ottawa Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Study Start: August 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

US (4); CA (1)