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

Monitoring Organ Donors to Increase Transplantation Results

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.

Study Overview

• Status: Completed
• Conditions: Transplantation
• Intervention / Treatment: Procedure: Protocolized care

• Study Type: Interventional
• Enrollment (Actual): 556
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Norcross, Georgia, United States, 30071
      • LifeLink of Georgia
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Lifebanc
    • Columbus, Ohio, United States, 43212
      • Lifeline of Ohio
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • LifeShare of Oklahoma
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15238
      • Center for Organ Recovey and Education
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Donor Services
  • Texas
    • Dallas, Texas, United States, 75231
      • Southwest Transplant Alliance-Dallas
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lifecenter North West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of organs transplanted.	At explantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of organs that are transplantable.	At Explantation
Expected Observed Ratio	At Explantation
Organ Recipient six month hospital free survival	6 months post transplant

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Health Resources and Services Administration (HRSA)

Publications and helpful links

General Publications

• Al-Khafaji A, Murugan R, Wahed AS, Lebovitz DJ, Souter MJ, Kellum JA; MOnIToR study investigators. Monitoring Organ Donors to Improve Transplantation Results (MOnIToR) trial methodology. Crit Care Resusc. 2013 Sep;15(3):234-40.
• Al-Khafaji A, Elder M, Lebovitz DJ, Murugan R, Souter M, Stuart S, Wahed AS, Keebler B, Dils D, Mitchell S, Shutterly K, Wilkerson D, Pearse R, Kellum JA. Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial. Intensive Care Med. 2015 Mar;41(3):418-26. doi: 10.1007/s00134-014-3621-0. Epub 2015 Jan 13.
• Li S, Wang S, Murugan R, Al-Khafaji A, Lebovitz DJ, Souter M, Stuart SRN, Kellum JA; Monitoring Organ Donors to Improve Transplantation Results (MOnIToR) Study Investigators. Donor biomarkers as predictors of organ use and recipient survival after neurologically deceased donor organ transplantation. J Crit Care. 2018 Dec;48:42-47. doi: 10.1016/j.jcrc.2018.08.013. Epub 2018 Aug 18.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (ESTIMATE): October 1, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Recipients; Organ Donors
• Other Study ID Numbers: R38OT10587