Prone vs Supine Position in Potential Organ Donors: Multicenter Clinical Trial

Summary

Background and justification: In Argentina, 9,650 people are on the organ transplant waiting list, including 290 who require a lung transplant. In 2022, 21 unilateral lungs, 18 bilateral lungs, and one cardiopulmonary block were implanted, representing only 1.9% of all transplants. Maintaining organ viability in potential donors (PD) is challenging because brain death triggers adrenergic activation, hemodynamic instability, and atelectasis due to mechanical ventilation and loss of respiratory muscle activity. These factors impair gas exchange and reduce the number of lungs suitable for transplantation.

Ventilatory management in PDs aims to preserve lung function, minimize risks of invasive mechanical ventilation (IMV), and maintain adequate gas exchange while preventing alveolar collapse and overdistension. Strategies derived from Acute Respiratory Distress Syndrome (ARDS) include recruitment maneuvers, which may cause complications. In contrast, prone positioning improves ventilation-perfusion matching and increases functional lung parenchyma.

This study proposes prone positioning as a preventive ventilatory strategy to optimize lung preservation in organ donors.

Objectives: (1) Determine whether early prone positioning after BD certification increases the proportion of lungs meeting suitability criteria for transplantation. (2) Evaluate its effect on the availability of other transplantable organs and on hemodynamic stability.

Methods: The PRODON-AR study is a prospective, multicenter, randomized controlled trial conducted in 10 intensive care units (ICUs) across Argentina. Recruitment began on June 1, 2023, and will continue until 250 PDs are enrolled. Participants will be randomly assigned to standard care (supine) or prone positioning following BD certification. Eligible donors will be those with confirmed BD, meeting multi-organ donation criteria, and without documented opposition to donation. Exclusion criteria include contraindications to prone positioning. Donors will be excluded from analysis if the interval between BD certification and proning exceeds 12 hours, if more than 20% of data for key variables are missing, or if clinical conditions require returning to the supine position.

The primary outcome is the number of lungs suitable for transplantation. Secondary outcomes include the number of organs transplanted, vasopressor requirements, and variables related to gas exchange and respiratory mechanics.

Conditions

• Prone Position
• Donors
• Lung Procurement
• Tissue Donors
• Lung Transplantation

Interventions

PROCEDURE

Prone position

The only intervention that differs between the groups will be that the potential donors assigned to the experimental group will be kept in a prone position until they enter the operating room for ablation.

Sponsors & Collaborators

• Hospital Cuenca Alta Néstor Kirchner Cañuelas

  collaborator UNKNOWN

• Hospital Escuela General José Francisco de San Martín (Corrientes)

  collaborator UNKNOWN

• Hospital Ángel Cruz Padilla (Tucuman)

  collaborator UNKNOWN

• Hospital Central de Mendoza

  collaborator UNKNOWN

• Hospital Simplemente Evita de Gonzalez Catan

  collaborator UNKNOWN

• HIGA Abraham Piñeyro

  collaborator UNKNOWN

• Hospital San Martín (Entre Ríos)

  collaborator UNKNOWN

• Hospital Interzonal General de Agudos San Roque

  collaborator UNKNOWN

• Hospital Regional Dr. Enrique Vera Barros (La Rioja)

  collaborator UNKNOWN

• Instituto Nacional Central Único Coordinador de Ablación e Implante

  collaborator OTHER_GOV

• Hospital de Alta Complejidad del Bicentenario Esteban Echeverría

  lead OTHER_GOV

Principal Investigators

• Pablo Centeno, Dr. · Hospital de Alta Complejidad del Bicentenario Esteban Echeverría

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2024-12-31

Completion

2025-05-01

Countries

• Argentina

Study Locations