title: Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.
abstract: BACKGROUND
  Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted.
  
  
  METHODS
  We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early.
  
  
  RESULTS
  We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86).
  
  
  CONCLUSIONS
  In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.
authors.affiliation: Center for Critical Care Nephrology, Department of Critical Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Al-Khafaji
authors.forename: Michele
authors.initials: M
authors.lastname: Elder
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lebovitz
authors.forename: Raghavan
authors.initials: R
authors.lastname: Murugan
authors.forename: Michael
authors.initials: M
authors.lastname: Souter
authors.forename: Susan
authors.initials: S
authors.lastname: Stuart
authors.forename: Abdus S
authors.initials: AS
authors.lastname: Wahed
authors.forename: Ben
authors.initials: B
authors.lastname: Keebler
authors.forename: Dorrie
authors.initials: D
authors.lastname: Dils
authors.forename: Stephanie
authors.initials: S
authors.lastname: Mitchell
authors.forename: Kurt
authors.initials: K
authors.lastname: Shutterly
authors.forename: Dawn
authors.initials: D
authors.lastname: Wilkerson
authors.forename: Rupert
authors.initials: R
authors.lastname: Pearse
authors.forename: John A
authors.initials: JA
authors.lastname: Kellum
mesh_terms: D000328:Adult; D001926:Brain Death; D002985:Clinical Protocols; D005260:Female; D005440:Fluid Therapy / Q000592:standards*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D014019:Tissue Donors; D009927:Tissue and Organ Procurement / Q000592:standards*