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临床试验/NCT03105271
NCT03105271已完成不适用

Acute Kidney Injury in Patients With Sickle Cell Disease

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Incidence of Acute Kidney Injury

研究概览

简要总结

Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during an admission for crisis and during well clinic follow-up.

详细描述

Patients admitted to the hospital for acute chest syndrome or vaso-occlusive pain events may consent to participate in this study. Patients will consent to daily blood and urine collection during their hospitalization and during well clinic visits.

Each AM, participants will have blood and urine collected, processed, and strored for future analysis of hemolytic markers and biomarkers of kidney injury. Patients will also have strict urine output recorded. Acute kidney injury (AKI) will be defined by the current KDIGO definition based on either a rise in serum creatinine or decline in urine output. Patient medical course will be reviewed to determine interventions and outcomes of their admission based on the development of AKI.

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
1 Year 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome
  • Able to sign informed consent

排除标准

  • 未提供

结局指标

主要结局

Incidence of Acute Kidney Injury

时间窗: Hospitalizations through study completion, an average of one year

Evaluate the incidence of KDIGO defined AKI among patients admitted for pain or acute chest syndrome. AKI is defined by KDIGO as an increase in SCr by 50% or ≥0.3mg/dL from baseline, or UOP \<0.5mL/kg/hr for 12 hrs

Impact of Acute Kidney Injury during Pain or Acute Chest Syndrome Hospitalizations on the Development of Chronic Kidney Disease as defined by KDIGO.

时间窗: One year

We will evaluate the impact of AKI on eGFR. To evaluate this impact, we will compare the change in eGFR, as measured by cystatin C, obtained from each patient during their non-acute clinic visit both immediately prior to their AKI events and after AKI events.

Impact of free heme and endothelin on development of AKI

时间窗: two years

We will test the hypothesis that free heme and endothelin are elevated in patients that develop AKI as compared to patients without AKI.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey D. Lebensburger, DO

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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