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临床试验/NCT02933450
NCT02933450已完成4 期

Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
43
试验地点
1
主要终点
Efficacy of Patiromer in Reducing Serum Potassium

研究概览

简要总结

The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the Investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (K greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.

详细描述

This is an open label pilot study. Thirty patients with ESRD who qualify for emergent dialysis on the basis of serum potassium greater than 6mEq/L will be randomly assigned, using a random number generator in blocks of sixes, to standard-of-care (standard care) or patiromer group. Patients in the patiromer group will be given a single dose of 25.2g of patiromer in addition to standard-of-care treatment after randomization. Standard-of-care is defined as intervention or care provided by clinical provider according to individual practice pattern or hospital protocol. Each group of 15 patients will be observed with telemetry monitoring for 10 hours or till hemodialysis units become available for treatment (whichever comes first). Blood draws and electrocardiograms (ECGs) will be performed at enrollment and at 1, 2, 4, 6, 8 and 10hrs thereafter. Serum will be analyzed for basic metabolic panel and magnesium. Medications, including potassium lowering agents, administered during this period will be documented.

  1. Informed consent will be obtained. 2. Subject will be randomized. 3. A. Randomized to Standard of Care (SOC): data will be collected on SOC treatment. 3. B. Randomized to patiromer group: subjects will receive a single dose of 25.2g of patiromer. SOC data will be collected. 4. all subjects will have blood drawn and ECGs (1 12 lead ECG and 1 Lead I Rhythm strip) done at baseline, 1, 2, 4, 6, 8 and 10 hours. Blood will be analyzed for basic metabolic panel and magnesium. 5. CRF completion-SOC data will be recorded in addition to current medications. 6. After subjects have received hemodialysis or reach the 10 hour study period, whichever comes first, the subject will be completed on the study.

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

入选标准

  • ESRD patients with serum potassium greater than or equal to 6.0 mEq/L
  • Emergent dialysis not expected to be available for 6 hours

排除标准

  • new clinically significant arrhythmia on initial ECG
  • patiromer is contraindicated
  • have received SPS

研究组 & 干预措施

Patiromer group

Active Comparator

Patiromer 25.2 g dose

干预措施: Patiromer 25.2 g (Drug)

结局指标

主要结局

Efficacy of Patiromer in Reducing Serum Potassium

时间窗: 6 hours

serial serum potassium levels will be graphed and compared between the 2 groups

次要结局

  • Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.(6 hours)

研究者

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

Zubaid Rafique

Principal Investigator

Baylor College of Medicine

研究点 (1)

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