Prone vs Supine Position in Potential Organ Donors: PRODONAR Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Potential lung donor
研究概览
简要总结
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.
详细描述
This protocol follows the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials).
Introduction: Organ transplantation replaces a failing organ with one from a donor. Ablation enables organ removal for therapeutic use in recipients with terminal organ failure. In Argentina, as of February 2023, 9,650 people were on the national waiting list, including 290 requiring lung transplantation. In 2022, 767 real donors generated 2,090 organs, of which only 40 lungs were transplanted, representing 1.9% of all transplants.
The lung remains one of the most challenging organs for procurement due to strict selection criteria and rapid functional deterioration after brain death (BD). Countries such as Spain, which lead global donation rates, have broadened donor criteria ("expanded criteria donors"), demonstrating that the use of marginal lungs does not increase recipient mortality.
Following BD, sympathetic nervous system activation triggers a massive inflammatory response leading to endothelial and alveolar damage. Potential donors (PDs) under invasive mechanical ventilation (IMV) experience additional inflammatory stress. Neuromuscular paralysis and a lack of respiratory effort promote atelectasis, particularly in dependent lung regions, thereby compromising ventilation-perfusion (V/Q) matching. The apnea test and FiO₂ 100% exposure can worsen atelectasis through nitrogen washout. In addition, an absent cough reflex predisposes to secretion retention and infection, reducing lung viability and secondarily impairing the function of other organs through systemic hypoxia and inflammation.
Rationale: Ventilatory management in PDs aims to preserve lung function, reduce IMV-induced injury, and maintain optimal gas exchange while preventing alveolar collapse and overdistension. Lung-protective ventilation (tidal volume 6-8 mL/kg predicted body weight and adequate positive end-expiratory pressure, PEEP) remains standard; however, the proportion of suitable lungs for procurement remains low.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who died under neurological criteria
- •18 to 70 years of age
- •Meet multi-organ donor criteria
- •That they have no opposition to the donation.
排除标准
- •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
研究组 & 干预措施
Prone position
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.
干预措施: Prone position (Procedure)
Supine position
Potential donors assigned to the control group (supine position) will continue in that position with the usual treatment.
结局指标
主要结局
Potential lung donor
时间窗: The assessment will be conducted within 1 hour before the potential donor enters the operating room for organ ablation.
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
Potential lung donor
时间窗: The assessment will be conducted within 1 hour before the potential donor enters the operating room for organ ablation.
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
次要结局
- 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)
- 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)