CompletedNot Applicable

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

4,210 participantsStarted 2015-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

All-cause mortality

Timeframe: 90 days post-randomisation

Trial details

NCT IDNCT02030158

SponsorAustralian and New Zealand Intensive Care Research Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Severe Sepsis and Septic Shock trials