NCT04123275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

March 18, 2019

Last Update Submit

October 9, 2019

Conditions

Tissue and Organ Procurement

Keywords

Validation studiesWithholding treatment

Outcome Measures

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)

    36 months

Secondary Outcomes (5)

  • Incidence of circulatory death in 60 minutes

    36 months

  • Incidence of circulatory death in 120 and 180 minutes

    36 months

  • Doses analgesia

    36 months

  • Doses sedation

    36 months

  • Incidence of withdrawal of endotracheal tube

    36 months

Interventions

No 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. .OTHER

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Jeroen Bosch Hospital

's-Hertogenbosch, 5223GZ, Netherlands

Location

University Medical Center Groningen

Groningen, 9713, Netherlands

Location

Radboud University Medical Center

Nijmegen, 5600HB, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015GD, Netherlands

Location

ETZ

Tilburg, 5022GC, Netherlands

Location

Isala clinics

Zwolle, 8025AB, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 35266926DERIVED

  • 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.

    PMID: 32459638DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

October 10, 2019

Study Start

July 7, 2015

Primary Completion

August 31, 2018

Study Completion

October 1, 2018

Last Updated

October 10, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(6)