A Retrospective Review of a Comprehensive Cohort of Septic Shock: Assessment of Critical Determinants of Outcome

NCT ID: NCT01775956

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2018-07-31

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

Conditions

Septic Shock

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anand Kumar

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anand Kumar, MD

Role: CONTACT

akumar61@yahoo.com

204-291-0372

Wendy Janz, RN

Role: CONTACT

wjanz@hsc.mb.ca

204-787-1405

Facility Contacts

Wendy Janz, RN

Role: primary

wjanz@hsc.mb.ca

204-787-1405

Other Identifiers

H2003:087

Identifier Type: -

Identifier Source: org_study_id