TransplantationMOnIToRNCT00987714
Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)
A study testing Protocolized care in people with Transplantation, run by University of Pittsburgh at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transplantation
- What is being tested?
- Protocolized care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Lifecenter North West
Bellevue, Washington, 98004
LifeBanc
Cleveland, Ohio, 44122
Lifeline of Ohio
Columbus, Ohio, 43212
Southwest Transplant Alliance-Dallas
Dallas, Texas, 75231
Tennessee Donor Services
Knoxville, Tennessee, 37909
LifeLink of Georgia
Norcross, Georgia, 30071
LifeShare of Oklahoma
Oklahoma City, Oklahoma, 73116
Center for Organ Recovey and Education
Pittsburgh, Pennsylvania, 15238
About this study
Official title: Monitoring Organ Donors to Increase Transplantation Results
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:
Read more
- 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.
- Conditions
- Transplantation
- Being tested
- Protocolized care
- Keywords
- Organ Donors, Recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized careProcedure or surgery
Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.
| Study group | Role | What they receive |
|---|---|---|
| Protocolized Care | Experimental | Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors. Receives: Procedure: Protocolized care |
| Standard Care | No intervention | This is the Organ Procurement Organization current practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of organs transplanted.
Measured: At explantation
Secondary outcomes (3)
Number of organs that are transplantable.
Measured: At Explantation
Expected Observed Ratio
Measured: At Explantation
Organ Recipient six month hospital free survival
Measured: 6 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TransplantationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, John Kellum, University of Pittsburgh
- Investigators
- John Kellum, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987714
- Sponsor's protocol ID
- R38OT10587
- Acronym
- MOnIToR
- Status last verified
- Apr 2018
- First submitted
- 30 Sep 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23944211Al-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.
PubMed 25583616Li 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.
PubMed 30172032
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Organ Donors to Increase Transplantation Results
- ClinicalTrials.gov ID
- NCT00987714
- Acronym / sponsor ID
- MOnIToR / R38OT10587
- Conditions
- Transplantation
- Keywords
- Organ Donors, Recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocolized Care | Experimental | Procedure: Protocolized careAlgorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors. |
| Standard Care | No intervention | –This is the Organ Procurement Organization current practices. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolized careOrgan Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure. | Procedure or surgery | Protocolized Care |
Primary outcome
Number of organs transplanted.
Time frame: At explantation
3 secondary outcomes
Number of organs that are transplantable.
Time frame: At Explantation
Expected Observed Ratio
Time frame: At Explantation
Organ Recipient six month hospital free survival
Time frame: 6 months post transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 23944211Al-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.
- Results publication: PubMed 25583616Al-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.
- Derived from this study: PubMed 30172032Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kellum, MD principal investigator
University of Pittsburgh
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized care in people with Transplantation, run by University of Pittsburgh at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of organs transplanted. (time frame: At explantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987714, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.