Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

This study has been completed.
Sponsor:
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

September 30, 2009
April 16, 2013
August 2009
March 2013   (final data collection date for primary outcome measure)
Number of organs transplanted. [ Time Frame: At explantation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00987714 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of organs that are transplantable. [ 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 ]
Not Provided
Not Provided
 
Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)
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:

  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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Transplantation
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.
  • Experimental: Protocolized Care
    Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.
    Intervention: Procedure: Protocolized care
  • No Intervention: Standard Care
    This is the Organ Procurement Organization current practices.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
556
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00987714
R38OT10587
No
John Kellum, University of Pittsburgh
University of Pittsburgh
Health Resources and Services Administration (HRSA)
Principal Investigator: John Kellum, MD University of Pittsburgh
University of Pittsburgh
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP