NCT02030158 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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. Epub 2013 Aug 30.
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.

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

Details for clinical trial NCT02030158

Clinical trial NCT02030158 - References