Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial

Intensive Care Medicine 2015; 41(3): 418-26

Aims
To determine whether protocolized fluid therapy would increase organs transplanted and improve survival in the recipients compared to usual care.

Interventions
Protocolized fluid therapy or usual care in organ procurement

Participants
578 organ donors, 279 assigned to protocolized care and 277 to usual care.

Outcomes
Primary outcome was number of organs transplanted per donor. Secondary outcomes included the number of organs procured, observed versus expected organs transplanted ratio, 6 month recipient survival and 6-month hospital-free survival in recipients.

Follow-up
12 months

CET Conclusions
This study unfortunately fell short of the intended inclusion numbers due to a lack of resources, to the extent that 556 donors were enrolled rather than the 960 required for the original power calculation. No difference in transplanted organs per donor was seen. There were considerable difficulties in implementing the intervention, such that only one third of coordinators reported strictly adhering to the protocol and less than one third of donors randomized to the intervention met the authors’ criteria for response. The study does highlight some of the difficulties in trying to implement a donor treatment where the complexity of intervention and logistical problems can get in the way of a relatively simple concept. When analysing results of pre-specified subgroups (ECD and donors over 65 years) there was no difference between study and control.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
No

Trial registration
Clinicaltrials.gov - NCT00987714

Funding source
Not reported