Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)
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:
- improve resuscitation of potential organ donors.
- improve organ function in donors.
- 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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Monitoring Organ Donors to Increase Transplantation Results|
- Number of organs transplanted. [ Time Frame: At explantation ] [ Designated as safety issue: No ]
- Number of organs that are transplantable. [ Time Frame: At Explantation ] [ Designated as safety issue: No ]
- Expected Observed Ratio [ Time Frame: At Explantation ] [ Designated as safety issue: No ]
- Organ Recipient six month hospital free survival [ Time Frame: 6 months post transplant ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Protocolized Care
Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.
Procedure: Protocolized care
Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.
No Intervention: Standard Care
This is the Organ Procurement Organization current practices.
|United States, Georgia|
|LifeLink of Georgia|
|Norcross, Georgia, United States, 30071|
|United States, Ohio|
|Cleveland, Ohio, United States, 44122|
|Lifeline of Ohio|
|Columbus, Ohio, United States, 43212|
|United States, Oklahoma|
|LifeShare of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73116|
|United States, Pennsylvania|
|Center for Organ Recovey and Education|
|Pittsburgh, Pennsylvania, United States, 15238|
|United States, Tennessee|
|Tennessee Donor Services|
|Knoxville, Tennessee, United States, 37909|
|United States, Texas|
|Southwest Transplant Alliance-Dallas|
|Dallas, Texas, United States, 75231|
|United States, Washington|
|Lifecenter North West|
|Bellevue, Washington, United States, 98004|
|Principal Investigator:||John Kellum, MD||University of Pittsburgh|