Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00987714
• Collaborator: Health Resources and Services Administration (HRSA) (U.S. Fed)
• Enrollment: 556
• Locations: 8
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 69.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transplantation	Procedure: Protocolized care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 556 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Monitoring Organ Donors to Increase Transplantation Results
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Protocolized Care Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.	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.
No Intervention: Standard Care This is the Organ Procurement Organization current practices.

Outcome Measures

Primary Outcome Measures

1. Number of organs transplanted. [At explantation]

Secondary Outcome Measures

1. Number of organs that are transplantable. [At Explantation]

2. Expected Observed Ratio [At Explantation]

3. Organ Recipient six month hospital free survival [6 months post transplant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LifeLink of Georgia	Norcross	Georgia	United States	30071
2	LifeBanc	Cleveland	Ohio	United States	44122
3	Lifeline of Ohio	Columbus	Ohio	United States	43212
4	LifeShare of Oklahoma	Oklahoma City	Oklahoma	United States	73116
5	Center for Organ Recovey and Education	Pittsburgh	Pennsylvania	United States	15238
6	Tennessee Donor Services	Knoxville	Tennessee	United States	37909
7	Southwest Transplant Alliance-Dallas	Dallas	Texas	United States	75231
8	Lifecenter North West	Bellevue	Washington	United States	98004

Sponsors and Collaborators

• University of Pittsburgh
• Health Resources and Services Administration (HRSA)

Investigators

• Principal Investigator: John Kellum, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: John Kellum, M.D., University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00987714
• Other Study ID Numbers: R38OT10587
• First Posted: Oct 1, 2009
• Last Update Posted: Apr 5, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by John Kellum, M.D., University of Pittsburgh: Organ Donors; Recipients

Study Results

No Results Posted as of Apr 5, 2018