Monitoring Organ Donors to Increase Transplantation Results (MOnIToR) (MOnIToR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987714
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : April 5, 2018
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
John Kellum, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Transplantation Procedure: Protocolized care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Monitoring Organ Donors to Increase Transplantation Results
Study Start Date : August 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of organs transplanted. [ Time Frame: At explantation ]

Secondary Outcome Measures :
  1. Number of organs that are transplantable. [ Time Frame: At Explantation ]
  2. Expected Observed Ratio [ Time Frame: At Explantation ]
  3. Organ Recipient six month hospital free survival [ Time Frame: 6 months post transplant ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987714

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
Sponsors and Collaborators
University of Pittsburgh
Health Resources and Services Administration (HRSA)
Principal Investigator: John Kellum, MD University of Pittsburgh