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NCT01968746 · ClinicalTrials.gov registry record
The AVERT Sepsis Investigation
A clinical trial, sponsored by Christiana Care Health Services.
- Completed
- Registry status
- 100
- Enrollment target
NCT01968746: Completed study, sponsored by Christiana Care Health Services.
NCT01968746 is a clinical trial that has completed, run by Christiana Care Health Services. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968746 has completed, sponsored by Christiana Care Health Services.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-04 |
What the finished NCT01968746 record still lists
NCT01968746 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01968746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01968746 about?
NCT01968746 is a clinical study titled "The AVERT Sepsis Investigation". 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 pro...
What is the current status of trial NCT01968746?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2012-08. Estimated completion is 2015-04.
Who is sponsoring clinical trial NCT01968746?
This trial is sponsored by Christiana Care Health Services, which has 82 total clinical trials registered on ClinicalTrials.gov.
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