Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

Completed · Not applicable

Conditions studied: Transplantation

In brief

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.

Key facts

Study ID

NCT00987714

Run by

University of Pittsburgh

People needed

556

Starts

2009-08-01

Expected to finish

2013-03-01

Last updated by the study team

2018-04-05

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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