Project 462951

Evaluation of 10°C as an optimal temperature for cold static lung preservation: A randomized controlled trial

462951

Evaluation of 10°C as an optimal temperature for cold static lung preservation: A randomized controlled trial

$489,600
Project Information
Study Type: Unclear
Research Theme: Clinical
Institution & Funding
Principal Investigator(s): Cypel, Marcelo; Keshavjee, Shaf
Co-Investigator(s): Del Sorbo, Lorenzo
Institution: University Health Network (Toronto)
CIHR Institute: Circulatory and Respiratory Health
Program: Project Grant
Peer Review Committee: Randomized Controlled Trials 2
Competition Year: 2022
Term: 3 yrs 0 mth
Abstract Summary

Currently, lungs donated for transplantation are preserved in an ice cooler at a temperature of around 4 °C. While on ice, several deleterious processes may occur, rendering organ viability after a short period of time. Recently, we have shown lung preservation at 10°C to be advantageous, improving cell viability and protecting organ function. Here, we propose to investigate whether 10°C as a standard preservation temperature for donor lungs can result in better outcomes for patients receiving a transplant. We aim to investigate this by performing a double-armed prospective multi-center randomized controlled trial, using both preservation temperatures in standard preservation practise. Briefly, when suitable donor lungs become available for a consented recipient, the donor lungs will be randomized to be preserved using either 10°C or the standard 4°C within a cooler of ice before the time of lung retrieval. The lungs will then follow their typical course until the time of implantation. Important post-transplant outcomes will be monitored such as the incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (primary outcome), recipient time on the ventilator, recipient length of stay in the intensive care unit (ICU) and hospital, 30-day and 1-year recipient survival, lung function at 1-year, incidence of acute rejection, and organ utilization rates. Positive findings from this study will allow for potentially more lungs available for transplantation, in an era in which the demand for organs vastly exceeds the supply. Furthermore, improved lung preservation at 10°C may lead to improved recipient outcomes, shortening post-transplant complications and reducing the time needed to recover within the intensive care unit and hospital.

No special research characteristics identified

This project does not include any of the advanced research characteristics tracked in our database.

Keywords
10 Degrees Cold Static Preservation Health Economic Analysis Lung Transplantation Semi-Elective Lung Transplantation Staff Well-Being Temperature Modulation