Clinical trial NCT01775956: A Retrospective Review of a Comprehensive Cohort of Septic Shock: Assessment of Critical Determinants of Outcome
Official title: A Retrospective Review of a Comprehensive Cohort of Septic Shock: Assessment of Critical Determinants of Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical charts from all patients coded as septic shock in an internal ICU registry since 1994.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion criteria.

* The primary analysis will include all patients admitted to the institution with a final diagnosis of septic shock (including transfers).

Exclusion criteria:

* ICU patients who do not have a diagnosis of septic shock
* These are the only Inclusion/Exclusion criteria.

Primary outcomes:
measure: Outcome as determined by treatment choices
timeFrame: Participants will be followed for the Average length of hospital stay 4-5 weeks
Secondary outcomes:
measure: Vasopressor use as a predictor of complications
timeFrame: Participants will be followed for the Average length of hospital stay 4-5 weeks
measure: Elements that predict complications in ICU
timeFrame: Participants will be followed for the Average length of hospital stay 4-5 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre, Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Anand Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: