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临床试验/NCT04721652
NCT04721652招募中不适用

Fluid Intake After Hemodialysis: Investigating the Relationship Between Time and Weight Gain During the Interdialytic Interval

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
4
主要终点
T50%IDWG

研究概览

简要总结

Interdialytic weight gain determines how much fluid (ultrafiltration) has to be removed during each hemodialysis session. High ultrafiltration volumes stress the organism and lead to a higher risk of death. Thirst is the main driving factor of interdialytic weight gain, and thirst is mainly driven by salt intake, molecules that increase blood tonicity (such as sugar in diabetics) and fluid loss (such as in dehydration and blood loss). It has been speculated that fluid loss during hemodialysis could increase the sense of thirst immediately following dialysis, but this statement requires further evidence.

详细描述

Overview: In this observational study, we will have a sample of approximately 20 patients on chronic thrice weekly HD self-monitor their weight gain and blood pressure during the interdialytic intervals for one week. Demographics, anthropometrics, HD prescription and treatment information will be recorded. Study participants will complete four questionnaires at the first study visit and will then be provided medical grade scales and a blood pressure monitor, and will be asked to prospectively record weight changes and blood pressure at home four times a day for one week using a logbook.

Patients with significant residual urinary volume and diabetes mellitus will not be recruited, the latter to remove the bias of blood glucose in determining osmotic thirst.

Home Body Weight Monitoring Study participants will be asked to perform daily home body weight monitoring for the duration of the whole study with medical grade scales. Study participants will be asked to monitor their body weight four times per day: upon waking up, between 12:00 and 2:00 pm, between 6:00 and 8:00 pm and at bedtime. Participants will be asked to wear similar clothing for all measurements. Monitoring will start after the first HD session of the week until the first HD session of the following week.

Home Blood Pressure Monitoring Study participants will be asked to perform daily home blood pressure monitoring for the duration of the whole study with a validated, automated device. Participants with an arteriovenous fistula or graft will be asked to measure blood pressure on the arm without the arteriovenous fistula or graft. Study participants will be asked to monitor blood pressure four times per day, concomitantly with their body weight. Study participants will be asked to record three consecutive blood pressure measurements in a sitting position, after 5 minutes of rest in a quiet room. Monitoring will start after the first HD session of the week until the first HD session of the following week.

Daily Reminders Study participants will be given the option to receive a daily reminder phone call for the duration of the whole study, to encourage compliance to the self-monitoring procedures and to encourage reproducibility (e.g. by wearing similar clothing at each measurement) to weighing procedures. The phone calls will be made from an in-hospital office phone by either the research coordinators or the Ph.D. student attached to this study, following a script. Participants can decline the option of receiving daily reminders.

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

入选标准

  • Age ≥ 18 years
  • Thrice weekly maintenance hemodialysis
  • Willing and able to provide written informed consent

排除标准

  • Diabetes Mellitus
  • Residual Urinary Volume > 500 ml/day
  • Being able to self-monitor one's body weight and blood pressure

研究组 & 干预措施

Hemodialysis Patients (nondiabetic)

Nondiabetic adult hemodialysis patients

结局指标

主要结局

T50%IDWG

时间窗: Up to one week

Time to achieve ≥50% cumulative interdialytic weight gain (T50%IDWG) from the last hemodialysis treatment

Cumulative IDWG% curve

时间窗: Up to one week

Shape of cumulative interdialytic weight gain curve (linear vs nonlinear)

次要结局

  • Comparisons between IDWG% curves(One week, Interdialytic intervals)
  • Daytime vs Nighttime cumulative IDWG%(One week, Interdialytic intervals)
  • Correlations of T50%IDWG(One week, Interdialytic intervals)
  • Correlations of Nighttime cumulative %IDWG(One week, Interdialytic intervals)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chris McIntyre

Principal Investigator, Director of The Lilibeth Caberto Kidney Clinical Research Unit

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (4)

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