Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)
This study has been completed.
Sponsor:
University of Pittsburgh
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
John Kellum, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00987714
First received: September 30, 2009
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Transplantation |
Procedure: Protocolized care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Monitoring Organ Donors to Increase Transplantation Results |
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Number of organs transplanted. [ Time Frame: At explantation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of organs that are transplantable. [ Time Frame: At Explantation ] [ Designated as safety issue: No ]
- Expected Observed Ratio [ Time Frame: At Explantation ] [ Designated as safety issue: No ]
- Organ Recipient six month hospital free survival [ Time Frame: 6 months post transplant ] [ Designated as safety issue: Yes ]
| Enrollment: | 556 |
| Study Start Date: | August 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987714
Locations
| United States, Georgia | |
| LifeLink of Georgia | |
| Norcross, Georgia, United States, 30071 | |
| United States, Ohio | |
| LifeBanc | |
| Cleveland, Ohio, United States, 44122 | |
| Lifeline of Ohio | |
| Columbus, Ohio, United States, 43212 | |
| United States, Oklahoma | |
| LifeShare of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Pennsylvania | |
| Center for Organ Recovey and Education | |
| Pittsburgh, Pennsylvania, United States, 15238 | |
| United States, Tennessee | |
| Tennessee Donor Services | |
| Knoxville, Tennessee, United States, 37909 | |
| United States, Texas | |
| Southwest Transplant Alliance-Dallas | |
| Dallas, Texas, United States, 75231 | |
| United States, Washington | |
| 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 |
More Information
No publications provided
| Responsible Party: | John Kellum, M.D., University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00987714 History of Changes |
| Other Study ID Numbers: | R38OT10587 |
| Study First Received: | September 30, 2009 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Organ Donors Recipients |
ClinicalTrials.gov processed this record on June 17, 2013