NCT04043871已完成不适用
Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure: Pilot Study
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年6月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Systolic blood pressure according to oscillometric curve
研究概览
简要总结
The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method will be accurate for measurement of systolic blood pressure with marked arterial stiffness as seen in patients with severe renal impairment. Also that the presence of arterial calcifications only changes the agreement between the SFATI method and the reference method (auscultatory method) if the calcifications are very severe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient under consultation in the Nephrology for severe renal impairment (defined by a glomerular filtration rate <30 mL / min, assessment within previous 3 months)
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant or breastfeeding
结局指标
主要结局
Systolic blood pressure according to oscillometric curve
时间窗: Day 0
mmHg measured by Systolic Foot-to-Apex Time Interval
Systolic blood pressure according to Korotkov sounds
时间窗: Day 0
mmHg measured by auscultatory method
次要结局
- Systolic blood pressure according to conventional oscillometric measurement(Day 0)
- Brachial artery calcium score(Day 0)
- Disease-associated patient characteristics(Day 0)
- Brachial pulse wave velocity(Day 0)
- Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm Hg(Day 0)
- Presence of arterial rigidity(Day 0)
研究者
研究点 (1)
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