Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

Not Applicable

Completed

• Conditions: Transplantation
• Interventions: Procedure: Protocolized care

• Registration Number: NCT00987714
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocolized Care	Protocolized care	Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.

Primary Outcome Measures

Name	Time	Method
Number of organs transplanted.	At explantation

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Tennessee Donor Services; 🇺🇸 Knoxville, Tennessee, United States

LifeShare of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Lifeline of Ohio; 🇺🇸 Columbus, Ohio, United States

Center for Organ Recovey and Education; 🇺🇸 Pittsburgh, Pennsylvania, United States

LifeBanc; 🇺🇸 Cleveland, Ohio, United States

LifeLink of Georgia; 🇺🇸 Norcross, Georgia, United States

Lifecenter North West; 🇺🇸 Bellevue, Washington, United States

Southwest Transplant Alliance-Dallas; 🇺🇸 Dallas, Texas, United States