Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

Details

• Alternative Title:
  Intensive Care Med
• Personal Author:
  Al-Khafaji, Ali ; Elder, Michele ; Lebovitz, Daniel J ; Murugan, Raghavan ; Souter, Michael ; Stuart, Susan ; Wahed, Abdus S. ; Keebler, Ben ; Dils, Dorrie ; Mitchell, Stephanie ; Shutterly, Kurt ; Wilkerson, Dawn ; Pearse, Rupert ; Kellum, John A
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• Corporate Authors:
  on behalf of the Monitoring Organ Donors to Improve Transplantation Results (MOnIToR) Study Investigators
• Description:
  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 multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases 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 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) twelve-month survival in transplant recipients. The study was stopped early. ; RESULTS ; We enrolled 556 donors; 279 protocolized care, 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 usual care 3.29 (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 was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 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.
• Keywords:
  • Organ donation
  • clinical trial
  • transplantation
  • functional hemodynamic monitoring
  • fluid management
  • brain death
  • Adult
  • Brain Death
  • Clinical Protocols
  • Female
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• Source:
  Intensive Care Med. 41(3):418-426
• Pubmed ID:
  25583616
• Pubmed Central ID:
  PMC4351113
• Document Type:
  Text
• Funding:
  UL1 TR000005/TR/NCATS NIH HHSUnited States/ ; UL1 RR024153/RR/NCRR NIH HHSUnited States/ ; R01DK083961/DK/NIDDK NIH HHSUnited States/ ; R01 DK083961/DK/NIDDK NIH HHSUnited States/ ; CS/08/08/17/DH_/Department of HealthUnited Kingdom/ ; R38OT1058/OT/OSTLTS CDC HHSUnited States/ ; RP_2014-04-022/DH_/Department of HealthUnited Kingdom/ ; UL1TR000005/TR/NCATS NIH HHSUnited States/
• Genre:
  Journal Article
• Volume:
  41
• Issue:
  3
• Download URL:
  https://stacks.cdc.gov/view/cdc/30520/cdc_30520_DS1.pdf
• File Type:
  [PDF - 670.25 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:1e44ba12836234708ab927928434348238fd35220c5b24a0bd8bcba3601a446b829f03dea6eea20ba220d110435ac9118ad7b93c617ab5b05c21c8d6fb55fdec