NCT00987714

Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

Monitoring Organ Donors to Increase Transplantation Results

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 556 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-10-01
• Last updated: 2018-04-05

Locations

8 sites across 1 country: United States