A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
研究概览
简要总结
To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra abdominal surgery.
详细描述
A prospective pilot single center study to investigate the potential of [TIMP-2].[IGFBP-7] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •≥ 18 years
- •High risk patients: General Surgery AKI Risk Index Class III, IV or V
- •Major abdominal surgery
排除标准
- •Ongoing acute kidney injury Stage 2/3
- •History of kidney transplant
研究组 & 干预措施
Nephro Check Test
We take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI
干预措施: Nephro Check Test (Device)
Nephro Check Test
We take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI
干预措施: serum creatinine measurement (Other)
serum creatinine measurement
This is the "Golden standard" to diagnose AKI
干预措施: Nephro Check Test (Device)
serum creatinine measurement
This is the "Golden standard" to diagnose AKI
干预措施: serum creatinine measurement (Other)
结局指标
主要结局
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
时间窗: 72 Hours
次要结局
- Number of participants who need renal replacement therapy(30 Days)
研究者
Veerle Van Mossevelde
Data Nurse
Universitair Ziekenhuis Brussel