跳至主要内容
临床试验/NCT05158153
NCT05158153终止4 期

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年10月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
1
试验地点
1
主要终点
The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment.

研究概览

简要总结

There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose of this pilot study is to see if we can feasibly and safely provide several changes to the way that dialysis is provided in outpatient dialysis centers which may improve the chances of recovery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute tubular necrosis by clinical nephrology team
  • Age ≥ 18 years
  • Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2
  • Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)

排除标准

  • Known loop diuretic allergy/intolerance
  • Dialysis duration > 3 months
  • Unable to consent
  • Clinical team declines to allow approach for study

研究组 & 干预措施

ORKID Bundled Intervention

Experimental

干预措施: ORKID Bundled Intervention (Other)

ORKID Bundled Intervention

Experimental

干预措施: Furosemide (Drug)

结局指标

主要结局

The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment.

时间窗: First two weeks of study intervention

Feasibility

次要结局

  • The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.(Study day 90)
  • Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.(Study day 90)
  • Time to Renal Recovery(Study day 90)
  • Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension(Study day 90)
  • Number of Participants Enrolled Per Month(Total study duration, anticipated 1 year)
  • Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled(Total study duration, anticipated 1 year)
  • Modified Dialysis Symptom Index Score(Study day 0, 7, 14, 28, and 90)
  • Kidney Disease Quality of Life-36 Score(Study day 0, 7, 14, 28, and 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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