Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury Subtitle: Urinary Molecular and Metabolic Signature of Postoperative Acute Kidney Injury (NavigateAKI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Occurrence of postoperative acute kidney injury (pAKI)
研究概览
简要总结
The risk for postoperative acute kidney injury (pAKI), as for any other postoperative complications (PC), comes from a number of interactions between a patient's health before surgery, strength to tolerate surgery and influences on the operating room environment. At this time doctors do not have good tools to predict which patients may be at risk of having this complication. The purpose of this research study is to develop a urine test that can be used to predict the risk for having problems with kidney function after major surgery.
详细描述
During hospitalization, a urine sample will be collected and additional tests will be added to the daily standard of care blood samples before, during and three times following an elective surgical procedure.
Study participants will complete telephone interviews at 6 and 12 months after discharge from the hospital with a study team member. The telephone interview will consist of a short questionnaire asking about state of health and a health survey.
At the same times of the phone interviews, the study team will mail a urine dipstick that is used to detect any amount of protein in the urine. Study participants will be asked to urinate on dipstick and send it back to the study team in provided shipping material.
Healthy Controls will be enrolled to establish baseline values for kidney health based upon a single urine collection and a brief health questionnaire.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence of postoperative acute kidney injury (pAKI)
时间窗: up to 7 days after surgery.
PostoperativeAKI is a change outcome of an increase of greater than or equal to 50% of creatinine from initial level prior to surgery until postoperative day 7.
次要结局
- Change from baseline in urine protein biomarkers at 4 hours after surgery(Baseline, 4 hours after surgery)
- Change from baseline in urine protein biomarkers at postoperative day 1(Baseline, day 1 after surgery)