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NCT Number: NCT00987714

Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

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.

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Key information

Conditions

Transplantation

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LifeLink of Georgia, Norcross, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protocolized care

Procedure

Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.

Primary outcomes

  1. Number of organs transplanted.

    Time frame: At explantation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

Monitoring Organ Donors to Increase Transplantation Results

Acronym: MOnIToR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2009
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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