Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01775956
Recruitment Status : Unknown
Verified July 2013 by Dr. Anand Kumar, University of Manitoba.
Recruitment status was:  Recruiting
First Posted : January 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Anand Kumar, University of Manitoba

Tracking Information
First Submitted Date January 16, 2013
First Posted Date January 25, 2013
Last Update Posted Date July 25, 2013
Study Start Date December 2003
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2013)
Outcome as determined by treatment choices [ Time Frame: Participants will be followed for the Average length of hospital stay 4-5 weeks ]
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2013)
  • Vasopressor use as a predictor of complications [ Time Frame: Participants will be followed for the Average length of hospital stay 4-5 weeks ]
    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 ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Medical charts from all patients coded as septic shock in an internal ICU registry since 1994.
Condition Septic Shock
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 24, 2013)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01775956
Other Study ID Numbers H2003:087
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Anand Kumar, University of Manitoba
Study Sponsor University of Manitoba
Collaborators Not Provided
Investigators
Principal Investigator: Anand Kumar, MD University of Manitoba
PRS Account University of Manitoba
Verification Date July 2013