The AVERT Sepsis Investigation
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2015 |
| Start Date: | August 2012 |
| End Date: | March 2015 |
| Contact: | Ryan Arnold, MD |
| Email: | RyArnold@christianacare.org |
| Phone: | (302) 733-4130 |
The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis
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.
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.
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
We found this trial at
4
sites
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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