Clinical trial NCT01968746: The AVERT Sepsis Investigation
Official title: The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Severe Sepsis
Keywords: Sepsis
Shock
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Therapeutic Monitoring Systems
name: MaRS Discovery District
First posted: 2013-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted through the ED for suspected infection as primary reason for admission.

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.


Eligibility 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

Primary outcomes:
measure: Progressive organ failure
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Newark
country: United States
facility: Christiana Health System
state: Delaware
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Christiana Care Health Services
name: Ryan Arnold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital
name: Andrew JE Seely, MD, PhD
role: STUDY_CHAIR
References: