NCT02030158

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

December 20, 2013

Last Update Submit

July 13, 2020

Conditions

Severe Sepsis and Septic Shock

Keywords

Severe sepsisSeptic shockEarly goal directed therapyIndividual patient data meta-analysis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    90 days post-randomisation

Secondary Outcomes (9)

  • Hospital mortality

    At hospital discharge (censored at 60 days)

  • 28-day mortality

    At 28 days from randomisation

  • Duration of survival

    from randomisation (censored at 90 days)

  • Duration of stay in the Intensive Care Unit (ICU)

    from ICU admission to ICU discharge (censored at 90 days)

  • Duration of stay in the Emergency Department (ED)

    From ED admission to ED discharge (censored at 72 hours)

  • +4 more secondary outcomes

Study Arms (2)

Early Goal-Directed Therapy (EGDT)

Protocolised resuscitation (termed Early Goal-Directed Therapy - EGDT)

Usual resuscitation

Usual resuscitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe sepsis and septic shock

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

    PMID: 11794169BACKGROUND

  • Delaney A, Peake SL, Bellomo R, Cameron P, Holdgate A, Howe B, Higgins A, Presneill J, Webb S; ARISE Investigators. Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan. Emerg Med Australas. 2013 Oct;25(5):406-15. doi: 10.1111/1742-6723.12116. Epub 2013 Sep 9.

    PMID: 24099368BACKGROUND

  • Power GS, Harrison DA, Mouncey PR, Osborn TM, Harvey SE, Rowan KM. The Protocolised Management in Sepsis (ProMISe) trial statistical analysis plan. Crit Care Resusc. 2013 Dec;15(4):311-7.

    PMID: 24289513BACKGROUND

  • Pike F, Yealy DM, Kellum JA, Huang DT, Barnato AE, Eaton TL, Angus DC, Weissfeld LA; ProCESS Investigators. Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan. Crit Care Resusc. 2013 Dec;15(4):301-10.

    PMID: 24289512BACKGROUND

  • ProCESS/ARISE/ProMISe Methodology Writing Committee; Huang DT, Angus DC, Barnato A, Gunn SR, Kellum JA, Stapleton DK, Weissfeld LA, Yealy DM, Peake SL, Delaney A, Bellomo R, Cameron P, Higgins A, Holdgate A, Howe B, Webb SA, Williams P, Osborn TM, Mouncey PR, Harrison DA, Harvey SE, Rowan KM. Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe. Intensive Care Med. 2013 Oct;39(10):1760-75. doi: 10.1007/s00134-013-3024-7. Epub 2013 Aug 30.

    PMID: 23958738BACKGROUND

  • PRISM Investigators; Rowan KM, Angus DC, Bailey M, Barnato AE, Bellomo R, Canter RR, Coats TJ, Delaney A, Gimbel E, Grieve RD, Harrison DA, Higgins AM, Howe B, Huang DT, Kellum JA, Mouncey PR, Music E, Peake SL, Pike F, Reade MC, Sadique MZ, Singer M, Yealy DM. Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis. N Engl J Med. 2017 Jun 8;376(23):2223-2234. doi: 10.1056/NEJMoa1701380. Epub 2017 Mar 21.

    PMID: 28320242DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

January 8, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

June 1, 2016

Last Updated

July 15, 2020

Record last verified: 2020-07