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Hamilton-DONATE: a city-wide pilot observational study of the ICU management of deceased organ donors

  • Frederick D’AragonEmail author
  • Deborah Cook
  • Sony Dhanani
  • Christine Ribic
  • Karen E. A. Burns
  • Aemal Akhtar
  • Lori Hand
  • Erika Arseneau
  • Cynthia Cupido
  • Heather Whittigham
  • Andrew Healey
  • Anne Julie Frenette
  • François Lamontagne
  • Maureen O. Meade
  • for the Canadian Critical Care Trials Group and the Canadian National Transplant Research Program
Reports of Original Investigations

Abstract

Purpose

Improving the medical care of deceased organ donors to increase transplant rates and improve allograft function requires an understanding of the current epidemiology and clinical practices of deceased donation within intensive care units (ICUs). Herein, we report the results of our investigation into the feasibility of a multicentre prospective cohort study addressing the afformentioned issues.

Methods

We conducted a 12-month prospective observational cohort study in six ICUs and one coronary care unit in Hamilton, Canada. We included consecutive children and adults following consent for deceased organ donation (including neurologic determination of death [NDD] or donation after circulatory death [DCD]). Intensive care unit research staff recorded donor management data from hospital records, extending from one day prior to the consent for organ donation up to the time of organ retrieval. The provincial Organ Donation Organization (ODO) supplemented these data and, additionally, provided data on corresponding organ recipients. We identified, evaluated, and measured three potential obstacles to the feasibility of a national cohort study: obtaining authorization to implement the study with a waiver of research consent, accessibility of transplant recipient data, and the time required to complete very detailed case report forms (CRFs), with valuable lessons learned for implementation in future projects.

Results

The local Research Ethics Board and the ODO Privacy Office both authorized the recording of donor and recipient study data with a waiver of research consent. Sixty-seven consecutive consented donors were included (31 NDD and 36 DCD donors); 50 of them provided 144 organs for transplantation to 141 recipients. We identified the age and sex of the recipients as well as the location and date of transplant for all organ recipients in Ontario; however, we obtained no recipient data for six organs transported outside of Ontario. Intensive care unit research staff estimated that future CRF completion will require five to seven hours per patient.

Conclusion

The Hamilton-DONATE pilot study supports the feasibility of a larger cohort study to describe the epidemiology and clinical practices related to deceased donor care in Canada.

Trial registration

wwwclinicaltrials.gov (NCT02902783). Registered 16 September 2016.

Hamilton-DONATE : une étude pilote observationnelle de la gestion en USI des donneurs d’organes décédés à l’échelle d’une ville

Résumé

Objectif

L’amélioration des soins de donneurs d’organes décédés pour augmenter les taux de transplantation et améliorer la fonction des allogreffes nécessite de comprendre l’épidémiologie et les pratiques cliniques actuelles du don d’organe de donneur décédé dans les unités de soins intensifs (USI). Nous présentons ici les résultats de notre enquête sur la faisabilité d’une étude de cohorte prospective multicentrique visant à répondre à ces questions.

Méthodes

Nous avons mené une étude de cohorte observationnelle prospective de 12 mois dans six USI et une unité de soins coronariens à Hamilton (Canada). Nous avons inclus les enfants et adultes consécutifs après consentement du don d’organe d’un donneur décédé (incluant la détermination neurologique du décès [DND] ou don après décès cardiocirculatoire [DDC]). Le personnel de recherche des unités de soins intensifs a consigné les données de la gestion médicale des donneurs à partir des dossiers hospitaliers, commençant une journée avant le consentement au don d’organe jusqu’au moment du prélèvement. L’organisme provincial responsable des dons d’organes (ODO) a complété ces données ainsi que celles des receveurs d’organes correspondants. Nous avons identifié, évalué et mesuré trois obstacles potentiels à la faisabilité d’une étude de cohorte nationale : l’obtention de l’autorisation de mise en place d’une étude avec dérogation de consentement à la recherche, l’accessibilité des données concernant les receveurs de greffes et le temps nécessaire pour remplir des cahiers d’observation très détaillés; nous en avons tiré des points importants pour la mise en œuvre de futurs projets.

Résultats

Le Comité local d’éthique de la recherche et le bureau de la protection de la vie privée de l’ODO ont tous deux autorisé l’enregistrement des données d’étude du donneur et du receveur avec une dérogation du consentement à la recherche. Soixante-sept donneurs consentants consécutifs (31 donneurs DND et 36 donneurs DDC) ont été inclus; parmi eux, 50 donneurs ont fourni 144 organes qui ont été greffés chez 141 receveurs. Nous avons identifié l’âge et le sexe des receveurs, ainsi que l’emplacement et la date de la transplantation pour tous les receveurs d’organes en Ontario; toutefois, nous n’avons pas obtenu de données pour six organes transportés hors de la province. Le personnel de recherche des unités de soins intensifs a estimé que le remplissage des cahiers d’observation futurs prendrait de 5 à 7 heures par patient.

Conclusion

L’étude pilote Hamilton-DONATE confirme la faisabilité d’une grande étude de cohorte visant à décrire l’épidémiologie et les pratiques cliniques pour les soins aux donneurs décédés au Canada.

Enregistrement de l’essai clinique

wwwclinicaltrials.gov (NCT02902783). Enregistré le 16 septembre 2016.

Notes

Acknowledgements

The authors sincerely thank Dr. Bram Rochwerg and Tina Millen from the Hamilton Health Sciences, Neala Hoad and France Clarke from St. Joseph’s Healthcare, Nancy Glover and Jodie Boltuc from Trillium Gift of Life Network, and Ruth Breau from McMaster University.

Competing interest

None declared.

Editorial responsibility

This submission was handled by Dr. Sangeeta Mehta, Associate Editor, Canadian Journal of Anesthesia.

Author contributions

All authors have made material contributions to this manuscript according to the rules of authorship of ICMJE. All authors contributed to the conception of the design, acquisition of data, analysis and interpretation of the data, drafted and revised the manuscript, and approved the final version to be published.

Sources of financial support

This work was supported by the Hamilton Health Sciences-RFA Research Strategic Initiative Program & New Investigator Funds.

Supplementary material

12630_2018_1179_MOESM1_ESM.pdf (120 kb)
TABLE DONATE-Pilot study—case report form edits. Supplementary material 1 (PDF 119 kb)

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Copyright information

© Canadian Anesthesiologists' Society 2018

Authors and Affiliations

  • Frederick D’Aragon
    • 1
    • 2
    • 12
    Email author
  • Deborah Cook
    • 3
    • 4
  • Sony Dhanani
    • 5
  • Christine Ribic
    • 3
  • Karen E. A. Burns
    • 4
    • 6
    • 7
  • Aemal Akhtar
    • 4
  • Lori Hand
    • 4
  • Erika Arseneau
    • 4
  • Cynthia Cupido
    • 8
  • Heather Whittigham
    • 3
  • Andrew Healey
    • 3
  • Anne Julie Frenette
    • 9
    • 10
  • François Lamontagne
    • 2
    • 11
  • Maureen O. Meade
    • 3
    • 4
  • for the Canadian Critical Care Trials Group and the Canadian National Transplant Research Program
  1. 1.Department of AnesthesiologyUniversité de SherbrookeSherbrookeCanada
  2. 2.Research Centre, Centre Hospitalier Universitaire de SherbrookeSherbrookeCanada
  3. 3.Department of MedicineMcMaster UniversityHamiltonCanada
  4. 4.Department of Health Research Methods, Evidence & ImpactMcMaster UniversityHamiltonCanada
  5. 5.Division of Critical Care, Department of Pediatrics Children’s Hospital of Eastern OntarioUniversity of OttawaOttawaCanada
  6. 6.Interdepartmental Division of Critical CareUniversity of TorontoTorontoCanada
  7. 7.Li Ka Shing Knowledge Institute, St. Michael’s HospitalTorontoCanada
  8. 8.Department of PediatricsMcMaster UniversityHamiltonCanada
  9. 9.Pharmacy facultyUniversité de MontréalMontrealCanada
  10. 10.Department of PharmacyHopital Sacre Coeur de MontrealMontrealCanada
  11. 11.Department of MedicineUniversité de SherbrookeSherbrookeCanada
  12. 12.Department of AnaesthesiaUniversité de SherbrookeSherbrookeCanada

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