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Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Three, International Trials Comparing Protocolised With Usual Resuscitation in Patients Presenting to the Emergency Department With Severe Sepsis and Septic Shock

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ClinicalTrials.gov Identifier: NCT02030158
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : July 15, 2020
Sponsor:
Collaborators:
Intensive Care National Audit & Research Centre
University of Pittsburgh
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Brief Summary:
This is the statistical analysis plan for an individual patient data meta-analysis (IPDMA) of three EGDT clinical trials.

Condition or disease
Severe Sepsis and Septic Shock

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Study Type : Observational
Actual Enrollment : 4210 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Three, International, Multicentre, Randomised, Controlled Trials Comparing Protocolised With Usual Resuscitation in Patients Presenting to the Emergency Department With Severe Sepsis and Septic Shock
Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Group/Cohort
Early Goal-Directed Therapy (EGDT)
Protocolised resuscitation (termed Early Goal-Directed Therapy - EGDT)
Usual resuscitation
Usual resuscitation



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 90 days post-randomisation ]

Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: At hospital discharge (censored at 60 days) ]
  2. 28-day mortality [ Time Frame: At 28 days from randomisation ]
  3. Duration of survival [ Time Frame: from randomisation (censored at 90 days) ]
  4. Duration of stay in the Intensive Care Unit (ICU) [ Time Frame: from ICU admission to ICU discharge (censored at 90 days) ]
    Measurement of duration will be standardised and analyses of these secondary/intermediate outcomes will use agreed, standard approaches that account for impact of survivorship

  5. Duration of stay in the Emergency Department (ED) [ Time Frame: From ED admission to ED discharge (censored at 72 hours) ]
    Measurement of duration will be standardised and analyses of these secondary/intermediate outcomes will use agreed, standard approaches that account for impact of survivorship

  6. Duration of stay in the hospital [ Time Frame: From hospital admission to hospital discharge (censored at 90 days) ]
    Measurement of duration will be standardised and analyses of these secondary/intermediate outcomes will use agreed, standard approaches that account for impact of survivorship

  7. Receipt of and duration of mechanical ventilation post-randomisation [ Time Frame: From randomisation to end of mechanical ventilation (censored at 90 days) ]
    Measurement of duration will be standardised and analyses of these secondary/intermediate outcomes will use agreed, standard approaches that account for impact of survivorship

  8. Receipt of and duration of vasopressor support post-randomisation [ Time Frame: From randomisation to end of vasopressor support (censored at 90 days) ]
    Measurement of duration will be standardised and analyses of these secondary/intermediate outcomes will use agreed, standard approaches that account for impact of survivorship

  9. Receipt of and duration of renal replacement therapy post-randomisation [ Time Frame: From randomisation to end of renal replacement therapy (censored at 90 days) ]
    Measurement of duration will be standardised and analyses of these secondary/intermediate outcomes will use agreed, standard approaches that account for impact of survivorship



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe sepsis and septic shock
Criteria

Inclusion Criteria:

* Enrolled into one of the three studies (ARISE, ProMISe or ProCESS) to either Early Goal Directed Therapy or usual resuscitation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030158


Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Intensive Care National Audit & Research Centre
University of Pittsburgh
Investigators
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Principal Investigator: Kathy Rowan Director, Intensive Care National Audit and Research Centre
Principal Investigator: Derek Angus Director, Clinical Research, Investigation, and Systems Modeling of Acute Illnesses, University of Pistburgh
Principal Investigator: Rinaldo Bellomo ANZIC-RC
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT02030158    
Other Study ID Numbers: ANZIC-RC/MR001
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
Severe sepsis
Septic shock
Early goal directed therapy
Individual patient data meta-analysis
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Emergencies
Shock
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation