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

NCT01775956 | Unknown

• 1 other identifier: H2003:087
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Medical charts from all patients coded as septic shock in an internal ICU registry since 1994.

You may qualify if:

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

You may not qualify if:

• ICU patients who do not have a diagnosis of septic shock

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Anand Kumar, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anand Kumar, MD

CONTACT

204-291-0372; akumar61@yahoo.com

Wendy Janz, RN

CONTACT

204-787-1405; wjanz@hsc.mb.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 25, 2013
• Study Start: December 1, 2003
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

CA (1)