The AVERT Sepsis Investigation

Sepsis Clinical Trial

— AVERT  

Official title:

The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968746
• Other study ID #: 602039
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: July 6, 2016
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
United States	Billings Clinic	Billings	Montana
United States	Cooper University Hospital	Camden	New Jersey
United States	Denver Health Medical Center	Denver	Colorado
United States	Christiana Health System	Newark	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
Christiana Care Health Services	MaRS Discovery District, Government of Ontario, Therapeutic Monitoring Systems

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progressive organ failure	A. SOFA score increase by = 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)	72 hours	No