Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

This study has been completed.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
John Kellum, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00987714
First received: September 30, 2009
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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 Intervention
Transplantation
Procedure: Protocolized care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Monitoring Organ Donors to Increase Transplantation Results

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Number of organs transplanted. [ Time Frame: At explantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 556
Study Start Date: August 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987714

Locations
United States, Georgia
LifeLink of Georgia
Norcross, Georgia, United States, 30071
United States, Ohio
LifeBanc
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)
Investigators
Principal Investigator: John Kellum, MD University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Kellum, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00987714     History of Changes
Other Study ID Numbers: R38OT10587
Study First Received: September 30, 2009
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Organ Donors
Recipients

ClinicalTrials.gov processed this record on July 29, 2014