Clinical trial NCT04131140: Organ Donation and End-of-life Decisions
Official title: Differences Across ICUs in Organ Donation After Brain Death: A Nationwide Study of Relationship With Variation in End-of-life Decisions
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Swedish Intensive Care Registry
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 12072
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: The Swedish Intensive Care Registry (SIR) collects a comprehensive data set of patient characteristics, intensive care procedures, severity of illness scores, workload and outcomes using detailed guidelines.

Continuous data are collected as raw data, validated locally and transferred electronically to the registry for central validation (confirmed to be within prespecified limits and inconsistencies and illogical entries identified). If necessary, data are returned for correction and revalidation before being accepted and added to the master database. No data are changed by SIR. At SIR's homepage there are numerous open reports, updated as soon as new incoming data are processed by SIR.

SIR has an annual 2-day course for all ICU's in registration techniques and problems and daily telephone support possibilities concerning registration questions, problems and guidance. SIR has, however not yet a systematic on-site auditing program.

Missing data regarding treatment strategy are registered and are accounted for in the study. There are no missing data regarding organ donation.

The investigators calculate the proportion of treatment limitations per ICU as the number of deaths with any treatment limitation divided by all deaths in the same ICU.

Continuous variables are expressed as mean (standard deviations) or median (interquartile range).

Differences in proportions are analysed using the χ2-test. Changes over time are analysed using the non-parametric trend test. Survival are examined using the Kaplan-Meier estimate and differences in survival are analysed with the log-rank test.

Logistic regression is used to examine associations between patient and ICU characteristics and DBD as dependent variable. Mixed-effects logistic regression clustered per ICU is used to assess associations between treatment limitation and DBD after adjusting for patient age, sex, comorbidities, the Simplified Acute Physiology Score III (SAPS3) probability of death, principal diagnostic category, presence of treatment limitation and type of hospital.

Significance was assumed if P \< 0.05.

Eligibility criteria: Inclusion Criteria:

All ICU deaths in Sweden between 1/1 2014 and 31/12 2017 from

1. general and neurological intensive care units,
2. which recorded treatment strategy according to national guidelines and
3. send data according to SIR's protocol for the follow-up of all deceased intensive care patients (DBD).

Exclusion Criteria:

1. 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.
2. General (N=3) ICUs that do not register documented treatment plan.

Primary outcomes:
measure: Rate of organ donations after brain death (DBD)
timeFrame: 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:
measure: Rate of documented treatment limitations during ICU stay
timeFrame: 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.
measure: Incidence and type of a documented treatment limitation during ICU stay
timeFrame: 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.
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: The Swedish Intensive Care Registry
Study officials:
affiliation: The Swedish Intensive Care Registry (http://icuregswe.org)
name: Thomas ÅI Nolin, MD
role: STUDY_DIRECTOR
affiliation: The Swedish Intensive Care Registry (http://icuregswe.org)
name: Nolin ÅI Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.