Abstract

We are conducting a very large randomized controlled trial involving 960 brain dead organ donors whom will be randomized 1:1 to an early goal-directed resuscitation arm versus usual care arm. The resuscitation protocol involves the use of fluid, vasopressors & inotropes. Cardiac output, mean arterial pressure and pulse pressure variation (as measure of fluid responsiveness) will be obtained by a minimally invasive, FDA approved hemodynamic monitor (LiDCO).

Data will be collected using data abstraction from the donor chart, data acquisition from the LiDCO device, and web based collection tools. We have organized our efforts under 3 integrated objectives: 1) conduct the trial and test whether protocolized care improves the number of organs for transplantation compared to usual care; 2) measure concentrations over time of IL-6 cytokine as a circulating marker for pro-inflammatory response and test whether protocolized resuscitation reduces expression of this marker; 3) assess the feasibility of the protocol administration in the community hospital setting where the majority of organ donation occurs.

This proposal is consistent with the recent HRSA emphasis on strategies to enhance organ yield for transplantation. If our goals are realized, the new and comprehensive data generated will be immediately generalizable to all OPOs throughout the nation and will have enormous implications for the public health of this country.

FAQs List:
  • What is the MOnIToR Study?
  • Who is conducting this study?
  • Who is funding this study?
  • When will the study start and how long is this study going on?
  • What are the potential benefits of this study?
  • What is the MOnIToR Study?

    This is a randomized, multicenter, clinical trial evaluating a protocolized resuscitation algorithm using a novel functional hemodynamic monitoring technology, to optimally resuscitate organ donors in order to increase organ yield for transplantation from brain dead organ donors. The organ procurement coordinator (OPC) will be trained to monitor certain hemodynamic parameters (Pulse Pressure variation (PPV), Mean Arterial Pressure and Cardiac Index (CI)) and institute management of the donors based on the algorithm.

    Who is conducting this study?

    This study is being conducted at several Organ Procurement Organizations throughout the United States. Please go to the sites to see the current list of Organ Procurement Organizations participating. The University of Pittsburgh Department of Critical Care Medicineís CRISMA Laboratory is the coordinating center for the study.

    Who is funding this study?

    This study is funded through a grant from The Department of Health Resources and Services Administration (HRSA) grant number R38OT10587. Click Here to go to the HRSA website.

    When will the study start and how long is this study going on?

    This study is scheduled to start enrolling donors in August 2009 and the active enrollment period for the 960 donors is currently 18 months.

    What are the potential benefits of this study?

    We canít say for sure what the benefits are to this study, however, previous research indicates that:
          1. Maintaining fluid balance or fluid optimization improves organ quality for transplantation from brain dead organ donors.
          2. Donors who are fluid optimized show an increase in the number of transplantable organs.
    This study was designed to answer the question whether optimal fluid resuscitation of organ donors using a protocol will improve the number of organs procured, as well as recipient survival following transplantation from brain dead organ donors.