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The AVERT Sepsis Investigation

NCT01968746 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2016-07-11

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Therapeutic Monitoring Systems

    collaborator OTHER

  • MaRS Discovery District

    collaborator OTHER

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Ryan Arnold, MD · Christiana Care Health Services

  • Andrew JE Seely, MD, PhD · Ottawa Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-01-31
Completion
2015-04-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968746 on ClinicalTrials.gov