Organ Donation and End-of-life Decisions

NCT04131140 | Completed

• 1 other identifier: EPN2017/247-32
• Study Type: observational
• Target: 12,072
• Locations: 1 country
• Sites: 1

Brief Summary

Variation in organ donation after brain death (DBD) per million population varies markedly between countries, within country regions, between and within intensive care units (ICU). These circumstances also apply to end-of-life decisions in the ICU. The investigators studied all ICU deaths in Sweden between 2014-2017 in ICUs that, as routine, registered treatment plan (no treatment limitation and/or treatment limitation) and DBD. The investigators hypothesized that ICUs with high proportion of treatment limitation (withholding or withdrawing life sustaining treatment) also had less proportion of DBD.

Conditions

Decision Making; Terminal Illness; Tissue and Organ Procurement

Keywords

Advance Care Planning; Resuscitation Orders; Palliative Care; Brain Death; Organ Donation; Critical Illness; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• Rate of organ donations after brain death (DBD)

  Documented decision to carry out organ donation

  The estimated period of time to the ICU death is assessed up to 5 months after patient admission time to the ICU, with a median of 1.6 days. The event is determined by clinical examination or, in some cases cerebral angiography.

Secondary Outcomes (2)

• Rate of documented treatment limitations during ICU stay

  The estimated period of time to the ICU documentation of treatment plan is assessed up to 5 months after patient admission time to the ICU, with a median of 14 hours. The event is determined by the note in patients medical record.

• Incidence and type of a documented treatment limitation during ICU stay

  The estimated period of time to the ICU documentation of WH and/or WD medical treatment is assessed up to 5 months after patient admission time to the ICU, with a median of 14 hours. The event is determined by the note in patients medical record.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of all ICU deaths (12,072) between 2014-2017 in general and neurological intensive care units which all recorded treatment strategy in their daily routine work. Special units like paediatric, burn and thoracic intensive care units were excluded

You may qualify if:

• All ICU deaths in Sweden between 1/1 2014 and 31/12 2017 from
• general and neurological intensive care units,
• which recorded treatment strategy according to national guidelines and
• send data according to SIR's protocol for the follow-up of all deceased intensive care patients (DBD).

You may not qualify if:

• Special units like paediatric (N=4), burn (N=2) and thoracic (N=8) intensive care units, due to low coverage ratio of documented treatment plan decisions in combination with a low ICU mortality rate.
• General (N=3) ICUs that do not register documented treatment plan.

Sponsors & Collaborators

• Swedish Intensive Care Registry: lead

Study Sites (1)

The Swedish Intensive Care Registry

Karlstad, Sweden

Location

Related Publications (7)

• Bendorf A, Kerridge IH, Stewart C. Intimacy or utility? Organ donation and the choice between palliation and ventilation. Crit Care. 2013 May 23;17(3):316. doi: 10.1186/cc12553.

  PMID: 23714404 BACKGROUND

• Parker M, Shemie SD. Pro/con ethics debate: should mechanical ventilation be continued to allow for progression to brain death so that organs can be donated? Crit Care. 2002 Oct;6(5):399-402. doi: 10.1186/cc1542. Epub 2002 Aug 15.

  PMID: 12398776 BACKGROUND

• Mark NM, Rayner SG, Lee NJ, Curtis JR. Global variability in withholding and withdrawal of life-sustaining treatment in the intensive care unit: a systematic review. Intensive Care Med. 2015 Sep;41(9):1572-85. doi: 10.1007/s00134-015-3810-5. Epub 2015 Apr 23.

  PMID: 25904183 BACKGROUND

• Citerio G, Cypel M, Dobb GJ, Dominguez-Gil B, Frontera JA, Greer DM, Manara AR, Shemie SD, Smith M, Valenza F, Wijdicks EFM. Organ donation in adults: a critical care perspective. Intensive Care Med. 2016 Mar;42(3):305-315. doi: 10.1007/s00134-015-4191-5. Epub 2016 Jan 11.

  PMID: 26754754 BACKGROUND

• Citerio G, Crippa IA, Bronco A, Vargiolu A, Smith M. Variability in brain death determination in europe: looking for a solution. Neurocrit Care. 2014 Dec;21(3):376-82. doi: 10.1007/s12028-014-9983-x.

  PMID: 24865268 BACKGROUND

• Neitzke G, Rogge A, Lucking KM, Boll B, Burchardi H, Dannenberg K, Duttge G, Dutzmann J, Erchinger R, Gretenkort P, Hartog C, Jobges S, Knochel K, Liebig M, Meier S, Michalsen A, Michels G, Mohr M, Nauck F, Salomon F, Seidlein AH, Soffker G, Stopfkuchen H, Janssens U. [Decision-making support in Intensive Care to facilitate organ donation : Position paper of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. Med Klin Intensivmed Notfmed. 2019 May;114(4):319-326. doi: 10.1007/s00063-019-0578-3. German.

  PMID: 30976838 BACKGROUND

• Long AC, Brumback LC, Curtis JR, Avidan A, Baras M, De Robertis E, Efferen L, Engelberg RA, Kross EK, Michalsen A, Mularski RA, Sprung CL; Worldwide End-of-Life Practice for Patients in ICUs (WELPICUS) Investigators. Agreement With Consensus Statements on End-of-Life Care: A Description of Variability at the Level of the Provider, Hospital, and Country. Crit Care Med. 2019 Oct;47(10):1396-1401. doi: 10.1097/CCM.0000000000003922.

  PMID: 31305497 BACKGROUND

Related Links

• Swedish Intensive Care Registry (SIR) is a national quality register for intensive care units.
• At the homepage of the Swedish Society for Anaesthesia and Intensive Care (SFAI) you find our national guidelines for treatment strategy in the intensive care units. English version at the link above.
• Sweden's national quality registries

MeSH Terms

Conditions

Brain Death; Critical Illness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Thomas ÅI Nolin, MD

  The Swedish Intensive Care Registry (http://icuregswe.org)

  STUDY DIRECTOR

• Nolin ÅI Thomas, MD

  The Swedish Intensive Care Registry (http://icuregswe.org)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 18, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: March 22, 2018
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)