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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
556
Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.
LifeLink of Georgia
Norcross, Georgia, United States
LifeBanc
Cleveland, Ohio, United States
Lifeline of Ohio
Columbus, Ohio, United States
LifeShare of Oklahoma
Oklahoma City, Oklahoma, United States
Center for Organ Recovey and Education
Pittsburgh, Pennsylvania, United States
Tennessee Donor Services
Knoxville, Tennessee, United States
Southwest Transplant Alliance-Dallas
Dallas, Texas, United States
Lifecenter North West
Bellevue, Washington, United States
Number of organs transplanted.
Time frame: At explantation
Number of organs that are transplantable.
Time frame: At Explantation
Expected Observed Ratio
Time frame: At Explantation
Organ Recipient six month hospital free survival
Time frame: 6 months post transplant
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