Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Recovery of kidney function
研究概览
简要总结
This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.
详细描述
Participants with moderate to severe acute kidney injury (AKI) who are discharged from participating centers (the University of Alabama at Birmingham Hospital, Vanderbilt University Medical Center, University of Kentucky) will be randomized to coming to a dedicated AKI clinic at one of the three recruitment centers for up to four visits over 3 months or usual care. At the visits to the AKI follow-up clinics, medicine reconciliation will be done, blood pressure will be measured, information on hospitalizations and other adverse events will be taken and blood and urine samples will be collected to check kidney function and store samples to measure biomarkers of AKI. Participants randomized to usual care will be contacted by telephone to review medications currently being taken and to collect information on hospitalizations and other adverse events. The primary outcome measures will be include both process of care and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients age 18 years and older
- •Patients who have developed moderate to severe AKI in the hospital, defined as:
- •At least a doubling of peak creatinine from baseline or receipt of dialysis while in the hospital
- •AKI of any degree in individuals with an estimated glomerular filtration (eGFR) rate < 60 ml/min/1.73m2 at baseline
- •AKI of any degree whose discharge creatinine does not return to within 50% of baseline.
- •Able to provide signed informed consent
排除标准
- •Patients with a history of kidney transplant
- •Patients who, in the opinion of the investigator, are not suitable to participate in the study
- •Unable to obtain written informed consent
- •prisoners or pregnant patients
结局指标
主要结局
Recovery of kidney function
时间窗: 90 days
Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months
Number of incorrectly prescribed medicines
时间窗: 90 days
The number of incorrectly dosed or prescribed medications that are detected or changed
Proportion of individuals restarting RAAS inhibitors
时间窗: 90 days
Proportion of patients with a class I indication for renin-angiotensin-aldosterone (RAAS) inhibitors who have appropriately re-started RAAS inhibitors within 3 months of discharge.
Blood pressure control
时间窗: 90 days
Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.
次要结局
- Major adverse kidney outcomes(90 days)
研究者
Orlando M. Gutierrez, MD, MMSc
Professor
University of Alabama at Birmingham