Predictors of Apnea and Prediction of Time to Death in Donation After Cardiac Death

NCT02430961 | Unknown

• 1 other identifier: UHN 15-9107
• Study Type: observational
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients can donate tissue and organs following death after withdrawal of life sustaining therapies (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this is a significant emotional and resource burden to families, healthcare workers and hospitals. A tool that allows accurate prediction of time to death following WLST (and thus the probability of successful donation) is urgently needed. Existing models have not been useful due to the lack of generalizability. Additionally, existing models have not included other important factors now recognized to be associated with time to death following WLST. The investigators will conduct a prospective, observational cohort study of all patients being considered for DCD in whom consent for donation is obtained to evaluate the association between neurologic and non-neurologic risk factors for apnea, other clinically important variables and time to death after WLST, and use these data to derive a generalizable predictive model for the prediction of the time to death following WLST in potential DCD donors.

Conditions

Tissue and Organ Procurement

Keywords

Critical Care; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Death (at 120 minutes)

  The primary outcome is death within 120 minutes of WLST. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest).

  120 minutes following withdrawal of life sustaining therapy

Secondary Outcomes (4)

• Death (at 60 minutes)

  60 minutes following withdrawal of life sustaining therapy

• Death (at 30 minutes)

  30 minutes following withdrawal of life sustaining therapy

• Warm Ischemic Time

  120 minutes following withdrawal of life sustaining therapy

• Number and Type of Organs procured

  24 hours following withdrawal of life sustaining therapy

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include all patients who are deemed eligible for DCD by Trillium Gift of Life Network (TGLN) and in whom informed consent for DCD is obtained from the substitute decision maker. All patients will be included in the study if they undergo withdrawal of life sustaining therapy for the potential of donation (whether they successfully donate or not). Any patient on mechanical ventilation who is 80 years of age or under is a potential DCD candidate if there is a plan for elective WLST.

You may qualify if:

• Planned withdrawal of life sustaining therapy
• Deemed eligible for DCD by Trillium Gift of Life
• Signed consent for DCD following withdrawal of life sustaining therapy

You may not qualify if:

• Refusal to or withdrawal of consent to DCD
• Patients in whom organs are deemed unsuitable for donation prior to withdrawal of life sustaining therapy

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Trillium Gift of Life Network, Ontario: collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Officials

• Jeffrey M Singh, MD

  University of Toronto / University Health Network

  PRINCIPAL INVESTIGATOR

• Laveena Munshi, MD

  University of Toronto / University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey M Singh, MD

CONTACT

416-603-5800; jeff.singh@uhn.ca

Laveena Munshi, MD

CONTACT

416-586-4800; laveena.munshi@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Director, Critical Care, Toronto Western Hospital and Assistant Professor, University of Toronto

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 30, 2015

Record last verified: 2015-04