Identifying Therapeutic Hemodialysis Targets Through Cerebrovascular Reactivity; RESPIRACT 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Baseline Doppler measurement Pre Dialysis Weekday Treatment
研究概览
简要总结
Patients with chronic kidney disease receiving hemodialysis (HD) suffer from higher rates of brain vascular disease and decreased cognition than the general population. One way to assess brain vascular health and response to HD stress, is to test how the brain's blood flow responds to carbon dioxide (CO2) to measure Cerebrovascular Reactivity (CVR). In this study, the investigators will compare the magnitude and speed of the brain's blood flow response to a step-wise change in CO2 with hemodynamic, dialysis, and cognitive parameters. The goal of the study is to establish therapeutic targets that can be altered during the dialysis procedure to protect the brain from HD stress.
详细描述
This is a follow-up study previously conducted by our lab group titled: "Hemodialysis Patients Have Impaired Cerebrovascular Reactivity to CO2 Compared to Chronic Kidney Disease Patients and Healthy Controls: A Pilot Study". It was determined that individuals who receive hemodialysis (HD) exhibited significant differences in their Cerebrovascular Reactivity (CVR) when compared to both healthy controls, and patients with kidney disease not yet on HD.
In this study, the aim is to determine if the degree of cognitive impairment is related to the degree of impaired brain blood flow response in order to determine therapeutic targets that may be altered during the dialysis procedure in order to preserve cognitive functioning in the patient's receiving HD, building upon the previous feasibility study.
This study will require 4 assessments over the course of 2 dialysis treatments (2 assessments per dialysis treatment [ie. pre and post HD assessments]). The subsequent dialysis treatment assessments will be completed in the course of a month to mitigate learning effects with regards to the cognitive assessment.
The study assessment includes:
- Measuring cerebrovascular reactivity (CVR) before and after hemodialysis (HD):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients ≥ 18 years old, receiving hemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
- •English proficiency
排除标准
- •Mental incapacity to consent
- •Declined to participate
- •Severe chronic obstructive lung disease (COPD) /Asthma
- •History of cerebrovascular accident (stroke, transient ischemic attack)
- •Previous neurosurgery
- •History of carotid stenosis or carotid surgery
- •History of vasculitis
- •Documented Dementia
- •Pregnancy
- •Not fluent in English
结局指标
主要结局
Baseline Doppler measurement Pre Dialysis Weekday Treatment
时间窗: 20 minutes to complete the assessment before HD treatment
The CVR diagnostic assessment also needs to include Doppler in order to obtain arterial blood flow velocity. This will be performed prior to the dialysis treatment by all consenting patients on a weekday HD session. Examining CVR before the dialysis session will allow for insight into the patient's baseline CVR function.
Baseline RespirAct measurement Pre Dialysis Weekday Treatment
时间窗: 20 minutes to complete the assessment before HD treatment
The CVR diagnostic assessment with the RespirAct will be performed prior to the dialysis treatment by all consenting patients on a weekday HD session. Examining CVR before the dialysis session will allow for insight into the patient's baseline CVR function. CVR via the RespirAct device is an automated breathing circuit that uses a gas bladder to control and deliver carbon dioxide (CO2). It has various gas cylinders that are used in order to obtain the correct increase in CO2 in each patient.
Baseline RespirAct measurement Pre Dialysis Weekend Treatment
时间窗: 20 minutes to complete the assessment before HD treatment
The CVR diagnostic assessment with the RespirAct will be performed prior to the dialysis treatment by all consenting patients on a weekend HD session. Examining CVR before the dialysis session will allow for insight into the patient's baseline CVR function. By timing this assessment after the weekend dialysis break insight into how CV is affected by fluid status can be observed. CVR via the RespirAct device is an automated breathing circuit that uses a gas bladder to control and deliver carbon dioxide (CO2). It has various gas cylinders that are used in order to obtain the correct increase in CO2 in each patient.
RespirAct measurement Post Dialysis Weekday Treatment
时间窗: 20 minutes to complete the assessment after HD treatment
The CVR diagnostic assessment with the RespirAct will be performed after the dialysis treatment by all consenting patients on a weekday HD session. Examining CVR after the dialysis session will allow for insight into how the patient's CVR function has been altered by the dialysis treatment. CVR via the RespirAct device is an automated breathing circuit that uses a gas bladder to control and deliver carbon dioxide (CO2). It has various gas cylinders that are used in order to obtain the correct increase in CO2 in each patient.
RespirAct measurement Post Dialysis Weekend Treatment
时间窗: 20 minutes to complete the assessment after HD treatment
The CVR diagnostic assessment with the RespirAct will be performed after the dialysis treatment by all consenting patients on a weekend HD session. Examining CVR after the dialysis session will allow for insight into how the patient's CVR function has been altered by the dialysis treatment. Specifically, HD sessions after the weekend dialysis break require higher ultrafiltration rates as more fluid is retained by the patients. This leads to a more aggressive treatment to get the patient down to their dry weight. Therefore, having this treatment follow the weekend break dialysis treatment the intensity of dialysis treatment and its effects on CVR can be assessed. CVR via the RespirAct device is an automated breathing circuit that uses a gas bladder to control and deliver carbon dioxide (CO2). It has various gas cylinders that are used in order to obtain the correct increase in CO2 in each patient.
Baseline Doppler measurement Pre Dialysis Weekend Treatment
时间窗: 20 minutes to complete the assessment before HD treatment
The CVR diagnostic assessment also needs to include Doppler in order to obtain arterial blood flow velocity. This will be performed prior to the dialysis treatment by all consenting patients on a weekday HD session. Examining CVR before the dialysis session will allow for insight into the patient's baseline CVR function while having more fluid retained, as there has been a weekend break since the last HD session.
Doppler measurement Post Dialysis Weekday Treatment
时间窗: 20 minutes to complete the assessment before HD treatment
The CVR diagnostic assessment also needs to include Doppler in order to obtain arterial blood flow velocity. This will be performed after the dialysis treatment by all consenting patients on a weekday HD session. Examining CVR after the dialysis session will allow for insight into whether the patient's CVR function was changed by the HD treatment.
Doppler measurement Post Dialysis Weekend Treatment
时间窗: 20 minutes to complete the assessment after HD treatment
The CVR diagnostic assessment also needs to include Doppler in order to obtain arterial blood flow velocity. This will be performed after the dialysis treatment by all consenting patients on a weekday HD session. Examining CVR after the dialysis session will allow for insight into whether the patient's CVR function was changed by the HD treatment. Having this treatment follow the weekend break dialysis treatment the intensity of dialysis treatment and its effects on CVR can be assessed.
次要结局
- Blood Collection-Pre Dialysis WeekendTreatment(Less than a minute to complete the assessment before HD treatment)
- Cambridge Brain Sciences Post Dialysis weekday assessment(Less than 10 minutes to complete the assessment after HD treatment)
- Heart Rate Monitoring by Finapres NOVA- weekday treatment(Duration of the CVR assessment and HD treatment (roughly 4.5 hours))
- Blood Collection- Pre Dialysis Weekday Treatment(Less than a minute to complete the assessment before HD treatment)
- Blood Collection-Post Dialysis Weekday Treatment(Less than a minute to complete the assessment after HD treatment)
- Blood Pressure Monitoring by Finapres NOVA- weekday treatment(Duration of the CVR assessment and HD treatment (roughly 4.5 hours))
- Mean Arterial Pressure Monitoring by Finapres NOVA- weekday treatment(Duration of the CVR assessment and HD treatment (roughly 4.5 hours))
- Blood Collection-Post Dialysis Weekend Treatment(Less than a minute to complete the assessment after HD treatment)
- Cambridge Brain Sciences Pre Dialysis weekend assessment(Less than 10 minutes to complete the assessment before HD treatment)
- Trails Making Test B Post Dialysis weekday assessment(Less than 2 minutes to complete the assessment after HD treatment)
- Heart Rate Monitoring by Finapres NOVA- weekend treatment(Duration of the CVR assessment and HD treatment (roughly 4.5 hours))
- Blood Pressure Monitoring by Finapres NOVA- weekend treatment(Duration of the CVR assessment and HD treatment (roughly 4.5 hours))
- Mean Arterial Pressure Monitoring by Finapres NOVA- weekend treatment(Duration of the CVR assessment and HD treatment (roughly 4.5 hours))
- Cambridge Brain Sciences Pre Dialysis weekday assessment(Less than 10 minutes to complete the assessment before HD treatment)
- Montreal Cognitive Assessment Pre Dialysis weekday assessment(Less than 5 minutes to complete the assessment before HD treatment)
- Montreal Cognitive Assessment Pre Dialysis weekend assessment(Less than 5 minutes to complete the assessment before HD treatment)
- Montreal Cognitive Assessment Post Dialysis weekend assessment(Less than 5 minutes to complete the assessment after HD treatment)
- Cambridge Brain Sciences Post Dialysis weekend assessment(Less than 10 minutes to complete the assessment after HD treatment)
- Montreal Cognitive Assessment Post Dialysis weekday assessment(Less than 5 minutes to complete the assessment after HD treatment)
- Trails Making Test A Pre Dialysis weekday assessment(Less than 1 minutes to complete the assessment before HD treatment)
- Trails Making Test A Post Dialysis weekday assessment(Less than 1 minutes to complete the assessment after HD treatment)
- Trails Making Test B Post Dialysis weekend assessment(Less than 2 minutes to complete the assessment after HD treatment)
- Trails Making Test A Pre Dialysis weekend assessment(Less than 1 minutes to complete the assessment before HD treatment)
- Trails Making Test A Post Dialysis weekend assessment(Less than 1 minutes to complete the assessment after HD treatment)
- Trails Making Test B Pre Dialysis weekday assessment(Less than 2 minutes to complete the assessment before HD treatment)
- Trails Making Test B Pre Dialysis weekend assessment(Less than 2 minutes to complete the assessment before HD treatment)
研究者
Chris McIntyre
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's