Fluid resuscitation in the management of early septic shock (FINESS): a randomized controlled feasibility trial.
BACKGROUND
It is unknown whether fluid resuscitation with colloid or crystalloid in patients with severe sepsis or septic shock is associated with an improvement in clinical outcome. This randomized controlled trial determined the feasibility of conducting a large trial testing resuscitation with pentastarch vs normal saline in early septic shock, powered for a difference in mortality.


METHODS
At three Canadian and one New Zealand academic centre, 40 patients with early septic shock defined by at least two systemic inflammatory response syndrome criteria, infectious source, and persistent hypotension after >or= 1 L of crystalloid fluid were recruited. Feasibility measures were patient recruitment, blinding of the study fluids, and acceptability of the goal directed algorithms. Boluses of blinded normal saline or pentastarch (500 mL - maximum 3 L or 28 mL x kg(-1)) were administered within goal directed care for the first 12 hr.


RESULTS
Of 161 patients screened, 121 were excluded and 40 patients were enrolled, for a recruitment rate of 0.75 patients/site/month. Only 57% of physicians and 54% of nurses correctly guessed the study fluid (P = 0.46 and P = 0.67, respectively). The goal directed algorithms were acceptable to 97% of physicians.


CONCLUSIONS
The ability to recruit patients in this pilot randomized controlled trial was below expectations. Blinding of study fluids was adequate, and resuscitation algorithms were acceptable to most physicians. Methods to improve recruitment are required to enhance the feasibility of conducting a multicentre fluid resuscitation trial in early septic shock.
McIntyre
Lauralyn A
LA
University of Ottawa Centre for Transfusion and Critical Care Research, Ottawa Hospital, Ottawa, Ontario, Canada. lmcintyre@ottawahospital.on.ca
Fergusson
Dean
D
Cook
Deborah J
DJ
Rankin
Nigel
N
Dhingra
Vinay
V
Granton
John
J
Magder
Sheldon
S
Stiell
Ian
I
Taljaard
Monica
M
Hebert
Paul C
PC
D000368:Aged; D000465:Algorithms; D001291:Attitude of Health Personnel; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D005440:Fluid Therapy / Q000379:methods* / Q000401:mortality; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010865:Pilot Projects; D010952:Plasma Substitutes / Q000627:therapeutic use*; D012151:Resuscitation / Q000379:methods* / Q000401:mortality; D012772:Shock, Septic / Q000401:mortality / Q000628:therapy*; D012965:Sodium Chloride / Q000627:therapeutic use; D016896:Treatment Outcome
D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D012965:Sodium Chloride