NCT07251777: PRODONAR

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

Completed NA Last updated 26 November 2025

What this trial tests

NA trial testing Prone position in Prone Position in 254 participants. Completed in 1 May 2025.

Timeline

1 June 2023

Primary endpoint
31 December 2024

1 May 2025

Quick facts

Lead sponsor	Hospital de Alta Complejidad del Bicentenario Esteban Echeverría
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	254
Start date	1 June 2023
Primary completion	31 December 2024
Estimated completion	1 May 2025
Sites	1 location across Argentina

Drugs / interventions tested

• Prone position

Conditions studied

• Prone Position — all drugs for Prone Position →
• Donors — all drugs for Donors →
• Lung Procurement — all drugs for Lung Procurement →
• Tissue Donors — all drugs for Tissue Donors →

Sponsor

Hospital de Alta Complejidad del Bicentenario Esteban Echeverría

Who can join

Adults 18 to 70, any sex, with Prone Position or Donors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.