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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Anand Kumar, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01775956
First received: January 16, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition
Septic Shock

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Review of a Comprehensive Cohort of Septic Shock: Assessment of Critical Determinants of Outcome

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Outcome as determined by treatment choices [ Time Frame: Participants will be followed for the Average length of hospital stay 4-5 weeks ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Vasopressor use as a predictor of complications [ Time Frame: Participants will be followed for the Average length of hospital stay 4-5 weeks ] [ Designated as safety issue: No ]

    1. 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.

    Captured in the data collection tool


  • Elements that predict complications in ICU [ Time Frame: Participants will be followed for the Average length of hospital stay 4-5 weeks ] [ Designated as safety issue: No ]

    2.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.

    Measured by the data collection tool



Estimated Enrollment: 10000
Study Start Date: December 2003
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775956

Contacts
Contact: Anand Kumar, MD 204-291-0372 akumar61@yahoo.com
Contact: Wendy Janz, RN 204-787-1405 wjanz@hsc.mb.ca

Locations
Canada, Manitoba
Health Sciences Centre, Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Wendy Janz, RN    204-787-1405    wjanz@hsc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Anand Kumar, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Anand Kumar, MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT01775956     History of Changes
Other Study ID Numbers: H2003:087
Study First Received: January 16, 2013
Last Updated: July 24, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 24, 2014