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临床试验/NCT05405348
NCT05405348已完成不适用

The Effect of Food Intake During Hemodialysis on Blood Pressure: A Non-randomized Experimental Trial

melek avcı2 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2019年1月1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
54
试验地点
2
主要终点
Effect of food consumption on intradialytic blood pressure

研究概览

简要总结

Intradialytic hypotension is one of the most common complications associated with food intake during hemodialysis. Whether patients should be allowed to eat during hemodialysis is still a moot point.

This nonrandomized experimental trial investigated the effect of food intake during hemodialysis on blood pressure of patients. The sample consisted of 54 chronic patients receiving hemodialysis treatment. Researchers monitored the patients in two hemodialysis sessions; first meeting (T0) and second meeting (T1) which is one week later from T0. In the first meeting which is ''hemodialysis in fed state'', they ate the standard food served by the clinic at regular hours which means routine care of hemodialysis clinic. In the second meeting which is ''hemodilaysis in fasting state'', they did not eat anything during hemodialysis which means intervention part of the study. Both hemodyalisis in fed and fasting state, researchers recorded patient's blood pressure were monitozied in the mid-hemodiyalsis sessions. Patient' s sociodemographic and disease characteristics were recorded. Patient' s blood pressure monitorized by the ambulatory blood pressure monitor.

详细描述

Researchers monitored the patients in two hemodialysis sessions; first meeting (T0) and second meeting (T1) which is one week later from T0. In the first meeting which is ''hemodialysis in fed state'', they ate the standard food (in clinic routine) served by the clinic at regular hours which means routine care of hemodialysis clinic. In the second meeting patients did not eat anything during hemodialysis which means intervention part of the study. Both hemodyalisis in fed and fasting state, researchers recorded patient's blood pressure were monitozied in the mid-hemodiyalsis sessions. Patient' s sociodemographic and disease characteristics were recorded. Patient' s blood pressure monitorized by the ambulatory blood pressure monitor.

Blood pressure measurements were made using Suntech Bravo Ambulatory Blood Pressure Monitoring (Morrisville, USA). Blood pressure was evaluated in the supine position with the use of a brachial cuff. The blood pressure measurement was made in the midweek dialysis session on the day of the measurement. Before the patient entered hemodialysis, an ambulatory blood pressure monitor was placed and blood pressure was measured at 15-minute intervals throughout the 4-hour hemodialysis session. A total of 16 measurements were made. The patients did not consume any food during the 4-hour dialysis session.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Being over the age of 18
  • Having CKD and being in the hemodialysis program
  • Having the ability to understand and speak
  • Being on HD treatment for 6 months or longer
  • Weight gain of 4 kg or less between two HD sessions
  • Standard HD is applied 3 days a week for 4 hours

排除标准

  • The patient's communication difficulties, speech and understanding deterioration,
  • Being on dialysis for less than 6 months,
  • Interdialytic weight gain of more than 4kg,
  • The patient is not suitable for blood pressure measurement from the arm,
  • The patient used antihypertensive before HD,
  • Entering HD less than or more than 3 days a week,
  • More or less than 4 hours of HD input.

结局指标

主要结局

Effect of food consumption on intradialytic blood pressure

时间窗: 3 month

Blood pressure measurements were made using Suntech Bravo Ambulatory Blood Pressure Monitoring (Morrisville, USA). Blood pressure was evaluated in the supine position with the use of a brachial cuff. The blood pressure measurement was made in the midweek dialysis session on the day of the measurement. Before the patient entered hemodialysis, an ambulatory blood pressure monitor was placed and blood pressure was measured at 15-minute intervals throughout the 4-hour hemodialysis session. A total of 16 measurements were made.

次要结局

未报告次要终点

研究者

发起方
melek avcı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

melek avcı

Department of Internal Medicine Nursing, MsC, RN

Akdeniz University

研究点 (2)

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