Organ Donation and End-of-life Decisions

October 17, 2019 updated by: Swedish Intensive Care Registry

Differences Across ICUs in Organ Donation After Brain Death: A Nationwide Study of Relationship With Variation in End-of-life Decisions

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

12072

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Karlstad, Sweden
        • The Swedish Intensive Care Registry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of organ donations after brain death (DBD)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of documented treatment limitations during ICU stay
Time Frame: 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.
Documented decision of treatment plan
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
Time Frame: 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.
Documented treatment plan is either 1) no treatment limitation or 2) treatment limitation, which then is specified as a) withholding (WH) and/or b) withdrawing (WD) of either mechanical ventilation (MV) and/or non-invasive ventilation (NIV) and/or continuous renal replacement therapy (CRRT) and/or vasoactive drugs.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Intensive Care Registry

Investigators

  • Study Director: Thomas ÅI Nolin, MD, The Swedish Intensive Care Registry (http://icuregswe.org)
  • Principal Investigator: Nolin ÅI Thomas, MD, The Swedish Intensive Care Registry (http://icuregswe.org)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 22, 2018

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN2017/247-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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