Sponsor study identifier
observational
10,000
1 country
1
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2013
Actual (reported)January 25, 2013
Actual (reported)January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Outcome as determined by treatment choices
Analysis will be used to examine critical therapeutic elements of outcome (choice of antibiotics, rapidity of initiation, use of multiple drug combinations, choice and speed of initiation of pressors, choice and degree of fluid resuscitation, etc). Preliminary analysis of data from 2800 charts suggests an annual incidence of incidence of septic shock in North America (without adjustment for age, sex or socioeconomic status) of approximately 175,000 annual cases, a lower number than has been suggested in some other studies. Further preliminary analysis suggests there is a critical relationship between rapidity of antibiotic initiation and source control implementation following onset of hypotension and outcome in septic shock (Kumar et al, CCM 2006).
Participants will be followed for the Average length of hospital stay 4-5 weeks
Vasopressor use as a predictor of complications
Participants will be followed for the Average length of hospital stay 4-5 weeks
Elements that predict complications in ICU
Participants will be followed for the Average length of hospital stay 4-5 weeks
Medical charts from all patients coded as septic shock in an internal ICU registry since 1994.
Health Sciences Centre, Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
Anand Kumar, MD
University of Manitoba
First Submitted
January 16, 2013
First Posted
January 25, 2013
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Estimated (date passed)Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 25, 2013
Record last verified: 2013-07
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Source: ClinicalTrials.gov.
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