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
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Condition or disease |
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Severe Sepsis and Septic Shock |

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 |

Group/Cohort |
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Early Goal-Directed Therapy (EGDT)
Protocolised resuscitation (termed Early Goal-Directed Therapy - EGDT)
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Usual resuscitation
Usual resuscitation
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- All-cause mortality [ Time Frame: 90 days post-randomisation ]
- Hospital mortality [ Time Frame: At hospital discharge (censored at 60 days) ]
- 28-day mortality [ Time Frame: At 28 days from randomisation ]
- Duration of survival [ Time Frame: from randomisation (censored at 90 days) ]
- 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
- 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
- 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
- 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
- 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
- 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

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

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
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Severe sepsis Septic shock Early goal directed therapy Individual patient data meta-analysis |
Sepsis Toxemia Shock, Septic Emergencies Shock |
Disease Attributes Pathologic Processes Infections Systemic Inflammatory Response Syndrome Inflammation |