NCT00987714

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. 1.improve resuscitation of potential organ donors.
  2. 2.improve organ function in donors.
  3. 3.increase organ recovery per donor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3.6 years

First QC Date

September 30, 2009

Last Update Submit

April 3, 2018

Conditions

Transplantation

Keywords

Organ DonorsRecipients

Outcome Measures

Primary Outcomes (1)

  • Number of organs transplanted.

    At explantation

Secondary Outcomes (3)

  • Number of organs that are transplantable.

    At Explantation

  • Expected Observed Ratio

    At Explantation

  • Organ Recipient six month hospital free survival

    6 months post transplant

Study Arms (2)

Protocolized Care

EXPERIMENTAL

Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.

Procedure: Protocolized care

Standard Care

NO INTERVENTION

This is the Organ Procurement Organization current practices.

Interventions

Protocolized carePROCEDURE

Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.

Protocolized Care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

LifeLink of Georgia

Norcross, Georgia, 30071, United States

Location

LifeBanc

Cleveland, Ohio, 44122, United States

Location

Lifeline of Ohio

Columbus, Ohio, 43212, United States

Location

LifeShare of Oklahoma

Oklahoma City, Oklahoma, 73116, United States

Location

Center for Organ Recovey and Education

Pittsburgh, Pennsylvania, 15238, United States

Location

Tennessee Donor Services

Knoxville, Tennessee, 37909, United States

Location

Southwest Transplant Alliance-Dallas

Dallas, Texas, 75231, United States

Location

Lifecenter North West

Bellevue, Washington, 98004, United States

Location

Related Publications (3)

  • 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.

    PMID: 23944211BACKGROUND

  • 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.

    PMID: 25583616RESULT

  • 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.

    PMID: 30172032DERIVED

Study Officials

  • John Kellum, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(8)