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临床试验/NCT03465007
NCT03465007已完成不适用

Effects of Corticosteroids on Intra-dialytic Hypotension

University of Jordan1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年10月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Intra-dialytic hypotension

研究概览

简要总结

Symptomatic hypotension during (or immediately following) hemodialysis complicates 5 to 30 percent of all dialysis treatments and is associated with increased morbidity and mortality. Kidney Disease Outcomes Quality Initiative (KDOQI) and European Best Practice Guidelines define intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmHg or a decrease in mean arterial pressure by 10 mmHg, providing the decrease in blood pressure is associated with clinical events and need for nursing interventions. Common causes of intradialytic hypotension include excessive or rapid ultrafiltration, high blood flow during dialysis, CHF, taking the antihypertensive medications prior to HD, and others. One of the possible reasons that is surprisingly has not been approached worldwide for intra-dialytic hypotension could be more prevalent adrenal insufficiency in ESRD patients or a delay in the appropriate rise of endogenous serum cortisol given hemodialysis is considered by all means a stressful condition to the body. Investigators will assess first the prevalence of intradialytic hypotension at JUH dialysis unit. Investigators will screen patients who developed intradialytic hypotension for adrenal insufficiency by ordering random am cortisol. Then Investigators will give IV Hydrocortisone 100 mg prior to HD to patients who developed intra-dialytic hypotension and monitor their BP response during the HD treatments for 3 HD sessions (1 week, 3 HD sessions). After that, the same patients will receive 100 mg normal saline for 3 HD sessions. Both the administrator and the patient will be blinded for the interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Care Provider)

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

  • Patients on hemodialysis who develop intra-dialytic hypotension.

排除标准

  • Adrenal insufficiency

研究组 & 干预措施

Hydrocortisone

Active Comparator

100mg Hydrocortisone will be administered prior to hemodialysis

干预措施: Hydrocortisone (Drug)

Placebo

Placebo Comparator

100mg normal saline will be administered prior to hemodialysis

干预措施: Normal saline (Drug)

结局指标

主要结局

Intra-dialytic hypotension

时间窗: 3 months

intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmHg or a decrease in mean arterial pressure by 10 mmHg.

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

Saif Aldeen AlRyalat

Researcher

University of Jordan

研究点 (1)

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