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CompletedNCT04123275DCDIIIUpdated Oct 10, 2019

Prediction on Time to Death in Potential Controlled Donation After Circulatory Death (cDCD) Donors (DCD III Study)

An observational study in Tissue and Organ Procurement, sponsored by Radboud University Medical Center. Completed at 6 sites in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by Radboud University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 75 Years
Sex
All
01

Study summary

A considerable number of potential cDCD donors do not convert into actual organ donors because circulatory arrest does not occur within the predefined timeframe of warm ischemia after withdrawal of life-sustaining treatment. The main objective of this study is to determine parameters predicting time to death in potential cDCD patients.

Read the detailed description

Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. Even though there is a well-established cDCD program in the Netherlands, there is still a considerable number of potential donors not being converted into actual organ donors. A potential cDCD donor poses considerable challenges in terms of a) identification of those dying within the predefined timeframe of warm ischemia, after withdrawal of life-sustaining treatment to circulatory arrest, b) managing them appropriately within the framework and resources of the intensive care unit, c) dealing with family expectations especially when failure to donation occurs, and d) efficient utilization of the organ procurement teams.

Factors associated with early circulatory collapse after treatment withdrawal include a younger age, non-triggered modes of artificial ventilation, high FiO2, the use of inotropes, and a low arterial pH. Another important factor which could influence the donor potential is end-of-life treatment. The practice of withdrawal of life support treatment (WLST) is highly variable between ICU's and countries. This influences the dying process and can thus have a large influence on the onset of cardio respiratory arrest. There is also wide variation in the use and dosage of additional sedation and analgesia during WLST and controversy exists regarding hastening or slowing down death.

Several attempts have been made to develop models to predict the time between treatment withdrawal and circulatory arrest, as this is crucial to a) proceed with organ donation, and b) the quality of the harvested organs. The selected patients however, where not always restricted to potential candidates for cDCD organ donation as patients with cancer and severe infection were also included.

Objective: Objectives of this study are: a) To determine parameters predicting time to death in potential cDCD patients b) To validate and update previous predicting models on time to death after withdrawal of life-sustaining treatment. c) To assess variation in withdrawal of life-sustaining treatment in the Netherlands and its influence on post mortal organ donor potential and actual post mortal organ donors.

Design and setting: Multicenter, observational, prospective cohort study of all potential cDCD patients of 3 university and 3 teaching hospitals in the Netherlands with diverse focus of attention

Methods: All potential cDCD patients participating in the cDCD protocol as defined by the Dutch Transplant Foundation admitted at the Intensive Care unit, will be included.

Participants: Mechanically ventilated ICU patients aged between 18 to 75 years. Brain dead patients will be excluded.

02

Conditions studied

  • Tissue and Organ Procurement

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Keywords

  • Validation studies
  • Withholding treatment
03

In context

Death

572 studies on the registry are indexed under Death; 111 are open to participants now.

This study's enrollment of 400 is above the median of 314 across 293 observational studies indexed under Death.

Browse Death studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All mechanically ventilated patients admitted at the Intensive Care Unit, aged between 18 and 75 years old who are eligible to enter the organ procurement protocol of the Dutch Transplant Foundation.

Inclusion criteria

  • mechanically ventilated patients
  • aged between 18 and 75 years old, where further treatment is futile.
  • patients should meet the criteria of potential cDCD donors as defined by the Dutch Transplant Foundation

Exclusion criteria

Exclusion Criteria:

  • non-intubated patients
  • younger than 18 years old
  • brain dead patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention wil be done. Patient characteristics and the standard care before and after withdrawal of life-sustaining treatment in all potential cDCD donors, will be studied. .
06

What researchers measure

Primary outcomes

  1. Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients

    Development of a prediction tool to detect time to circulatory death (in minutes) in controlled donation after circulatory death patients (cDCD)

    Time frame: 36 months

Secondary outcomes

  1. Incidence of circulatory death in 60 minutes

    Number of patients with circulatory death within 60 minutes

    Time frame: 36 months

  2. Incidence of circulatory death in 120 and 180 minutes

    Number of patients when circulatory death occurs within the timeframe of 120 and 180 minutes

    Time frame: 36 months

  3. Doses analgesia

    Doses analgesia provided before and during withdrawal of life support in milligrams per hour

    Time frame: 36 months

  4. Doses sedation

    Doses sedation provided before and during withdrawal of life support in milligrams per hour

    Time frame: 36 months

  5. Incidence of withdrawal of endotracheal tube

    Number of endotracheal tubes removed

    Time frame: 36 months

07

Study locations

6 sites
  • Jeroen Bosch Hospital
    Den Bosch, 5223GZ, Netherlands
  • University Medical Center Groningen
    Groningen, 9713, Netherlands
  • Radboud University Medical Center
    Nijmegen, 5600HB, Netherlands
  • Erasmus Medical Center
    Rotterdam, 3015GD, Netherlands
  • ETZ
    Tilburg, 5022GC, Netherlands
  • Isala clinics
    Zwolle, 8025AB, Netherlands
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References and documents

Publications

  • Kotsopoulos A, Vos P, Witjes M, Volbeda M, Franke H, Epker J, Sonneveld H, Simons K, Bronkhorst E, Mullers R, Jansen N, van der Hoeven H, Abdo WF. Prospective Multicenter Observational Cohort Study on Time to Death in Potential Controlled Donation After Circulatory Death Donors-Development and External Validation of Prediction Models: The DCD III Study. Transplantation. 2022 Sep 1;106(9):1844-1851. doi: 10.1097/TP.0000000000004106. Epub 2022 Mar 8. PubMed 35266926 ↗
  • Kotsopoulos AMM, Vos P, Jansen NE, Bronkhorst EM, van der Hoeven JG, Abdo WF. Prediction Model for Timing of Death in Potential Donors After Circulatory Death (DCD III): Protocol for a Multicenter Prospective Observational Cohort Study. JMIR Res Protoc. 2020 Jun 23;9(6):e16733. doi: 10.2196/16733. PubMed 32459638 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04123275
Lead sponsor
Radboud University Medical Center
Responsible party
Sponsor
First posted
Oct 10, 2019
Start date
Jul 7, 2015
Primary completion
Aug 31, 2018
Completion
Oct 2018
Last update
Oct 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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