Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

University of Pittsburgh

Status: Completed

Conditions: Transplantation

Treatments: Procedure: Protocolized care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00987714

R38OT10587

Details and patient eligibility

About

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.

Enrollment: 556 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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556 participants in 2 patient groups

Protocolized Care

Experimental group

Description:

Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.

Treatment:

Procedure: Protocolized care

Standard Care

No Intervention group

Description:

This is the Organ Procurement Organization current practices.

Sponsor of this trial

Lead Sponsor

University of Pittsburgh

Collaborating Sponsor

Health Resources and Services Administration (HRSA)