Septic Shock Clinical Trial
Official title:
A Retrospective Review of a Comprehensive Cohort of Septic Shock: Assessment of Critical Determinants of Outcome
Septic shock remains the dominant cause of death in ICU's of the developed world with
approximately 400,000 cases annually in the US and another 20,000 annually in Canada. While
many retrospective and prospective reviews of septic shock patients have been undertaken
worldwide, many key questions remain unanswered. These questions include the true incidence,
associated morbidity and mortality of septic shock in North America, key factors associated
with successful management and markers suggesting a high probability of a complicated
clinical course. Part of the reason for the persistence of these questions, is the fact that
previous and ongoing reviews of septic shock and severe sepsis have been either limited in
number (typically <150) or biased by the need to be eligible for specific clinical trials
(typically, non-eligible patients have not been followed and had data collected.
We propose to examine specific questions within a temporally comprehensive cohort of septic
shock patients by review of individual charts using a defined data-extraction template.
Objectives
- Determination of impact of rapidity of implementation of antibiotic therapy, source
control (where required) and fluid resuscitation on mortality of septic shock
- Utility of persistence or increase of vasopressor needs over the 1st 24 hours of shock
as a predictor of a complicated ICU course (ICU duration > 1 week) or death
- Assessment of initial biochemical parameters, co-morbidities and new onset organ
failure at admission as predictors of a complicated ICU course (ICU duration > 1 week)
and death
Data Collection: Data collection would be performed by a combination of study nurses and 2nd
or 3rd year medical students hired for the summer for this research project. Research nurses
and student will be trained by the principal investigator. A minimum of 10% of the charts
will be randomly audited by the principal investigator to ensure appropriate data
extraction. This will allow the PI to review and correct any discrepant coding issues and
judge specific questions (e.g. appropriateness of antibiotics/presence of effective
antibiotics or not).
Data Collection Tool: Attached. In addition, data in the ICU registry includes basic
epidemiologic data (age, sex, all pertinent medical/surgical comorbidities/risk factors,
etc) as well as all Apache II
;
Observational Model: Case-Only, Time Perspective: Retrospective
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