Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

Study Overview
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Brief Summary
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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: improve resuscitation of potential organ donors. improve organ function in donors. 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.

Official Title
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Monitoring Organ Donors to Increase Transplantation Results

Conditions
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Transplantation

Intervention / Treatment
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* Procedure: Protocolized care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocolized Care<br>Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors. | Procedure: Protocolized care<br>* Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.<br>|
| No Intervention: Standard Care<br>This is the Organ Procurement Organization current practices. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of organs transplanted. |  | At explantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ Donors, Recipients