Transplantation
Conditions
Keywords
Organ Donors, Recipients
Brief summary
The objective of this study is to determine whether protocol guided resuscitation of brain dead organ donors using Pulse Pressure Variation (PPV) will increase the number of organs transplanted per donor. Specifically the study aims to: 1. improve resuscitation of potential organ donors. 2. improve organ function in donors. 3. increase organ recovery per donor. The investigators will randomize 960 subjects to either protocolized resuscitation (n=480) using a consensus-based PPV-guided algorithm or usual care using a 1:1 randomization scheme. The primary outcome is the mean number of organs transplanted per donor. Secondary outcomes include 6mHFS (six-month hospital-free survival) in the recipients, and mean number of organs procured per donor that are suitable for transplantation (intention to transplant). The study is powered to detect a 0.5 organ increase for transplantation per donor.
Interventions
PROCEDUREProtocolized care
Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.
Sponsors
Health Resources and Services Administration (HRSA)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Donors who were declared brain dead per local hospital brain death criteria. * Donors who are deemed suitable for organ donation by the local OPO whether they meet the standard criteria or the extended criteria for donation. * Presence of functioning arterial catheter.
Exclusion criteria
* Inability to obtain informed consent from donor next of kin or legal representative. * Donors less than 16 years of age, no maximum age limit. * Inability to perform hemodynamic monitoring. * Patients on lithium therapy prior to brain death. * Known severe aortic regurgitation, intra-cardiac shunts, or on intra-aortic balloon pump. * Donors previously enrolled in experimental protocol in which cytokines are the therapeutic targets (e.g. anti-TNF antibodies). * Donors receiving chemotherapy or with any disease state (e.g. AIDS) that renders the subject leukopenic (WBC count \< 2). * Donors receiving anti-leukocyte drugs (e.g. OKT3) regardless of their WBC counts. * Pregnant donors. * Donor is on ECMO machine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of organs transplanted. | At explantation |
Secondary
| Measure | Time frame |
|---|---|
| Number of organs that are transplantable. | At Explantation |
| Expected Observed Ratio | At Explantation |
| Organ Recipient six month hospital free survival | 6 months post transplant |
Countries
United States
Outcome results
None listed