Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

Transplantation Clinical Trial

— MOnIToR  

Official title:

Monitoring Organ Donors to Increase Transplantation Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987714
• Other study ID #: R38OT10587
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: April 3, 2018
• Start date: August 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Lifecenter North West	Bellevue	Washington
United States	LifeBanc	Cleveland	Ohio
United States	Lifeline of Ohio	Columbus	Ohio
United States	Southwest Transplant Alliance-Dallas	Dallas	Texas
United States	Tennessee Donor Services	Knoxville	Tennessee
United States	LifeLink of Georgia	Norcross	Georgia
United States	LifeShare of Oklahoma	Oklahoma City	Oklahoma
United States	Center for Organ Recovey and Education	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of organs transplanted.		At explantation
Secondary	Number of organs that are transplantable.		At Explantation
Secondary	Expected Observed Ratio		At Explantation
Secondary	Organ Recipient six month hospital free survival		6 months post transplant