Cell Cycle Arrest Proteins for Early Diagnosis of Acute Kidney Injury After Solid Organ Transplant: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- acute kidney injury
研究概览
简要总结
Renal failure is a common complication of lung transplant (LUTX) and orthotopic liver transplantation (OLTX). Early diagnosis of acute kidney injury (AKI) in this cohort is of utmost importance, since AKI after solid organ transplant is associated with worsened short and long-term outcomes. To now, early biomarkers of renal failure based on the measurement of cell-cycle arrest proteins have never been tested in this population.
详细描述
Bilateral lung transplantation (LUTX) is a surgical procedure offered to patients suffering from chronic respiratory failure. LUTX provides a survival benefit to selected patients but is associated with several short-term and long-term non-pulmonary complications.
Liver Transplantation (OLTX) is the gold-standard treatment for patients affected by end-stage liver disease or primary liver tumor. Despite its encouraging post-transplant survival, the increasing use of extended criteria donors leads to a higher incidence of post-LT complications that could affect post-LT results and quality of life.
Acute kidney failure (AKI) is frequent and associated with short-term and long-term morbidity and increased mortality. Indeed, AKI occurs in up to two-thirds of transplanted patients, with 5-13% needing renal replacement therapy (RRT), and associated with mortality ranging from 13 to 50%.
Several risk factors may favor postoperative AKI in patients undergoing solid organ transplant: preoperative (e.g., the patients' preoperative renal function and comorbidities) , intraoperative (i.e., hypoxia, hypotension, massive blood components' transfusions, use of intraoperative extracorporeal membrane oxygenation - ECMO) and postoperative (i.e., use of nephrotoxic agents as tacrolimus and antibiotics).
In patients treated with solid organ transplant, postoperative AKI increases ICU and hospital length of stay and is associated with worsened survival. At the same time, postoperative AKI is associated with an increase in end-stage renal failure and consequent chronic renal failure with potential needs of chronic RRT. Finally, AKI may determine graft dysfunction with direct and indirect mechanisms (i.e., inability to reach therapeutic targets of anti-rejection drugs).
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enlistment for bilateral LUTX
- •Enlistment for bilateral OLTX
- •Age > 18 years
- •Signed informed consent
排除标准
- •Age < 18 years old
- •Urgency enlistment
- •Already undergone solid organ transplant
- •Preoperative use of RRT
结局指标
主要结局
acute kidney injury
时间窗: <7 days from transplant
according to KIDGO guidelines
次要结局
- acute kidney disease(< 90 days from transplant)
研究者
Giacomo Grasselli
Prof
Policlinico Hospital
