Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Primary graft dysfunction
研究概览
简要总结
The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema
- •No restrictions regarding donor lungs (marginal donors, EVLP possible)
- •No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)
排除标准
- •Single-lung transplantation
- •Heart-lung transplantation
- •Re-transplantation
- •Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)
- •Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling
- •No access to the femoral artery possible
- •Severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary
结局指标
主要结局
Primary graft dysfunction
时间窗: 72 hours after transplantation
次要结局
未报告次要终点
研究者
Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD
Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD
Medical University of Vienna