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临床试验/NCT06348589
NCT06348589已完成不适用

Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis - an Observational Study

Vrinnevi Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年4月8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
25
试验地点
1
主要终点
Intra-dialytic systolic blood pressure fall of 20 mmHg or larger

研究概览

简要总结

High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.

详细描述

Background: Hypertension is an independent risk factor for development of end-stage renal disease and is the leading risk factor for cardiorenal death. It is estimated that more than 80% of patients with end-stage renal disease who undergo maintenance hemodialysis have hypertension. Intensified blood pressure control has been associated with reduced risk of death in patients with hypertension and chronic kidney disease but may increase the risk for intra-dialytic blood pressure falls in patients who undergo hemodialysis. Hemodialysis-associated hypotension has been associated with increased risks for cardiovascular disease and mortality.

Aim: The aim of this observational pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.

Ethics: The study has been approved by the Swedish Ethical Review Authority (2023-05959-01).

Study participants: All patients (n=70) with chronic kidney disease who undergo maintenance hemodialysis at Vrinnevi Hospital in Norrköping, Sweden, will be invited to voluntarily participate in the study. Information about the study will be given orally and in written form. Those who opt to participate will be asked to sign a written informed consent.

Background data collection: For descriptive purposes, information will be collected regarding current and prior medical diagnoses, current medical treatment, anthropometric data, and self-perceived quality of lite (using the validated questionnaire KDQOL-SF). Blood samples will be tested for routine hematological variables, as well as for sodium, potassium, calcium, creatinine, urea and HbA1c.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient undergoing hemodialysis treatment at Vrinnevi Hospital, Norrköping Sweden
  • Provision of written informed consent
  • Ability to understand instructions and to participate in the investigations

排除标准

  • Ongoing acute illness
  • Hospitalization within 4 weeks prior to enrollment
  • Unability to provide informed consent

结局指标

主要结局

Intra-dialytic systolic blood pressure fall of 20 mmHg or larger

时间窗: Up to 1 week

Difference between pre-dialytic and intra-dialytic systolic blood pressure

Post-dialytic orthostatic systolic blood pressure fall of 20 mmHg or larger

时间窗: Up to 1 week

Change between supine and upright systolic blood pressure

次要结局

未报告次要终点

研究者

发起方
Vrinnevi Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Wijkman

Principal Investigator, Medically Responsible Physician at the Section for Endocrinology and Diabetology

Vrinnevi Hospital

研究点 (1)

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