跳至主要内容
临床试验/NCT05907434
NCT05907434已完成不适用

Cell Cycle Arrest Proteins for Early Diagnosis of Acute Kidney Injury After Solid Organ Transplant: a Prospective Observational Study

Policlinico Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年2月1日最近更新:
适应症

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

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

发起方
Policlinico Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giacomo Grasselli

Prof

Policlinico Hospital

研究点 (1)

Loading locations...

相似试验