The PRECISE RCT: evolution of an early septic shock fluid resuscitation trial.
Severe sepsis and septic shock are the most common reasons for admission to an intensive care unit; and the risk of death is substantial, estimated at approximately 40%. Evidence suggests that early resuscitation strategies that include the use of resuscitation fluids, antibiotics, blood, and inotropes reduce death. Although fluid resuscitation is an immediate life-saving intervention, a fundamental question that remains unanswered is whether the type of resuscitation fluid impacts survival when it is initiated very early in the course of septic shock. A randomized controlled trial published in 2008 confirmed that hydroxyethyl starch fluids cause acute renal failure defined by the requirement for renal replacement therapy. In contrast, a subgroup analysis from a randomized controlled trial suggests that 4% albumin fluid may reduce death from severe sepsis; however, these findings require confirmation in a large randomized trial. Our team is planning a pragmatic early septic shock fluid resuscitation trial that will compare the effectiveness of 5% albumin vs normal saline on 90-day mortality (PRECISE). In this article, we summarize the scientific rationale and inherent challenges associated with the conduct of PRECISE, the background work and planning elements that have been undertaken, and the PRECISE RCT protocol with rationale and justifications provided for the chosen population, the interventions, and the outcome measures.
The Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Ottawa, Ontario, Canada. lmcintyre@toh.on.ca
Lauralyn
L
McIntyre
Dean A
DA
Fergusson
Brian
B
Rowe
Deborah J
DJ
Cook
Yaseen
Y
Arabi
Sean M
SM
Bagshaw
Marcel
M
Emond
Simon
S
Finfer
Alison
A
Fox-Robichaud
Alasdair
A
Gray
Robert
R
Green
Paul
P
Hebert
Eddy
E
Lang
John
J
Marshall
Ian
I
Stiell
Alan
A
Tinmouth
Joe
J
Pagliarello
Alexis
A
Turgeon
Timothy
T
Walsh
Andrew
A
Worster
Ryan
R
Zarychanski
D000328:Adult; D000368:Aged; D000418:Albumins / Q000378:metabolism; D003422:Critical Care / Q000379:methods; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D017052:Hospital Mortality; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000737:chemistry; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D017582:Renal Replacement Therapy / Q000379:methods; D012107:Research Design; D012151:Resuscitation / Q000379:methods* / Q000401:mortality; D012492:Salts / Q000737:chemistry; D012772:Shock, Septic / Q000628:therapy*; D016896:Treatment Outcome
D000418:Albumins; D006895:Hydroxyethyl Starch Derivatives; D012492:Salts