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

NCT07251777 | Completed

• 1 other identifier: 1168576558
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prone position; Donors; Lung procurement; Tissue donors; Mechanical Ventilation; Brain Death; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Potential lung donor

  Before the potential donor enters the operating room for organ ablation, it will be determined whether the individual is eligible to be a lung donor based on the criteria established by the Spanish Transplant Society

  The assessment will be conducted within 1 hour before the potential donor enters the operating room for organ ablation.

Secondary Outcomes (2)

• Organs ablated and implanted

  Data will be collected from the INCUCAI website up to 2 days post-ablation, following the procedure

• Vasopressor requirement

  The vasopressor requirement will be evaluated at three time points: 1. Immediately after the diagnosis of brain death (BD) 2. At 12 hours after the diagnosis of BD 3. Prior to entering the operating room for organ ablation

Study Arms (2)

Prone position

EXPERIMENTAL

Potential donors assigned to the experimental group will be placed in a prone position. This position will be maintained until one hour prior to entering the operating room for organ ablation.

Procedure: Prone position

Supine position

NO INTERVENTION

Potential donors assigned to the control group (supine position) will continue in that position with the usual treatment.

Interventions

Prone position PROCEDURE

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.

Prone position

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who died under neurological criteria
• to 70 years of age
• Meet multi-organ donor criteria
• That they have no opposition to the donation.

You may not qualify if:

• Patients who have expressly stated that they do not donate organs
• Patients who, for some reason, cannot establish a prone position
• Deceased with contraindication for organ donation.
• Elimination criteria
• Time between diagnosis of ME and prone greater than 12 hours
• Loss of more than 20% of data on main variables.
• Require changing a patient from the prone to the supine position for any reason

Sponsors & Collaborators

• Hospital de Alta Complejidad del Bicentenario Esteban Echeverría: lead
• Hospital Cuenca Alta Néstor Kirchner Cañuelas: collaborator
• Hospital Escuela General José Francisco de San Martín (Corrientes): collaborator
• Hospital Ángel Cruz Padilla (Tucuman): collaborator
• Hospital Central de Mendoza: collaborator
• Hospital Simplemente Evita de Gonzalez Catan: collaborator
• HIGA Abraham Piñeyro: collaborator
• Hospital San Martín (Entre Ríos): collaborator
• Hospital Interzonal General de Agudos San Roque: collaborator
• Hospital Regional Dr. Enrique Vera Barros (La Rioja): collaborator
• Instituto Nacional Central Único Coordinador de Ablación e Implante: collaborator

Study Sites (1)

Hospital de Alta Complejidad del Bicentenario Esteban Echeverría

Monte Grande, Buenos Aires, 1842, Argentina

Location

Related Publications (9)

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Maciel CB, Greer DM. ICU Management of the Potential Organ Donor: State of the Art. Curr Neurol Neurosci Rep. 2016 Sep;16(9):86. doi: 10.1007/s11910-016-0682-1.

  PMID: 27498101 BACKGROUND

• Del Rio F, Escudero D, De La Calle B, Vidal FG, Paredes MV, Nunez JR. [Evaluation and maintenance of the lung donor]. Med Intensiva. 2009 Jan-Feb;33(1):40-9. doi: 10.1016/s0210-5691(09)70304-3. Spanish.

  PMID: 19232208 BACKGROUND

• Meyfroidt G, Gunst J, Martin-Loeches I, Smith M, Robba C, Taccone FS, Citerio G. Management of the brain-dead donor in the ICU: general and specific therapy to improve transplantable organ quality. Intensive Care Med. 2019 Mar;45(3):343-353. doi: 10.1007/s00134-019-05551-y. Epub 2019 Feb 11.

  PMID: 30741327 BACKGROUND

• Bansal R, Esan A, Hess D, Angel LF, Levine SM, George T, Raoof S. Mechanical ventilatory support in potential lung donor patients. Chest. 2014 Jul;146(1):220-227. doi: 10.1378/chest.12-2745.

  PMID: 25010965 BACKGROUND

• Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

  PMID: 28973363 BACKGROUND

• Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

  PMID: 23688302 BACKGROUND

• Vieillard-Baron A, Charron C, Caille V, Belliard G, Page B, Jardin F. Prone positioning unloads the right ventricle in severe ARDS. Chest. 2007 Nov;132(5):1440-6. doi: 10.1378/chest.07-1013. Epub 2007 Oct 9.

  PMID: 17925425 BACKGROUND

• Matejovic M, Rokyta R Jr, Radermacher P, Krouzecky A, Sramek V, Novak I. Effect of prone position on hepato-splanchnic hemodynamics in acute lung injury. Intensive Care Med. 2002 Dec;28(12):1750-5. doi: 10.1007/s00134-002-1524-y. Epub 2002 Oct 26.

  PMID: 12447518 BACKGROUND

Related Links

• Ministerio de Salud de Argentina
• It is the computer system for the administration, management, supervision and consultation of the procurement and transplantation of organs, tissues and cells at the national level.

MeSH Terms

Conditions

Brain Death

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pablo Centeno, Dr.

  Hospital de Alta Complejidad del Bicentenario Esteban Echeverría

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The PRODON-AR study is a prospective, longitudinal, multicenter, randomized, parallel group, unblinded trial with electronic-based randomization

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: November 26, 2025
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: May 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)