NCT01968746

The AVERT Sepsis Investigation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Christiana Care Health Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Severe Sepsis

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2013-10-24
• Last updated: 2016-07-11

Locations

5 sites across 2 countries: United States, Canada