The AVERT Sepsis Investigation (AVERT)
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|ClinicalTrials.gov Identifier: NCT01968746|
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : July 11, 2016
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:
- To study the ability of a change in composite variability (∆CVI) assessment to act as a prognostic aid in predicting disease progression in sepsis.
- 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 or disease|
|Sepsis Severe Sepsis|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||April 2015|
|ED patients with suspected infection|
- Progressive organ failure [ Time Frame: 72 hours ]A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968746
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|United States, Delaware|
|Christiana Health System|
|Newark, Delaware, United States, 19718|
|United States, Montana|
|Billings, Montana, United States, 59101|
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada|
|Principal Investigator:||Ryan Arnold, MD||Christiana Care Health Services|
|Study Chair:||Andrew JE Seely, MD, PhD||Ottawa Hospital|