Clinical trial NCT00987714: Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)
Official title: Monitoring Organ Donors to Increase Transplantation Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplantation
Keywords: Organ Donors
Recipients
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2009-10-01
Enrollment: 556
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of organs transplanted.
timeFrame: At explantation
Secondary outcomes:
measure: Number of organs that are transplantable.
timeFrame: At Explantation
measure: Expected Observed Ratio
timeFrame: At Explantation
measure: Organ Recipient six month hospital free survival
timeFrame: 6 months post transplant
Other outcomes:
Locations:
city: Norcross
country: United States
facility: LifeLink of Georgia
state: Georgia
city: Cleveland
country: United States
facility: LifeBanc
state: Ohio
city: Columbus
country: United States
facility: Lifeline of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: LifeShare of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: Center for Organ Recovey and Education
state: Pennsylvania
city: Knoxville
country: United States
facility: Tennessee Donor Services
state: Tennessee
city: Dallas
country: United States
facility: Southwest Transplant Alliance-Dallas
state: Texas
city: Bellevue
country: United States
facility: Lifecenter North West
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: John Kellum, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 Care Med. 2015 Mar;41(3):418-26. doi: 10.1007/s00134-014-3621-0. Epub 2015 Jan 13.
citation: Li S, Wang S, Murugan R, Al-Khafaji A, Lebovitz DJ, Souter M, Stuart SRN, Kellum JA; Monitoring Organ Donors to Improve Transplantation Results (MOnIToR) Study Investigators. Donor biomarkers as predictors of organ use and recipient survival after neurologically deceased donor organ transplantation. J Crit Care. 2018 Dec;48:42-47. doi: 10.1016/j.jcrc.2018.08.013. Epub 2018 Aug 18.