Acute Effect of Protein Intake During Dialysis on Intradialytic Blood Pressure, 24-hour Ambulatory Blood Pressure and Arterial Stiffness Indices in Maintenance Hemodialysis Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Effect of meal versus no meal consumption during hemodialysis on intradialytic blood pressure
研究概览
简要总结
Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.
详细描述
A series of demographic, anthropometric and clinical data will be collected prior to enrollment. The intervention will last 3 consecutive weeks. Eligible subjects will be randomised to one group (high or low protein meals during dialysis) for one week (3 dialysis sessions). Second week will be a wash out period (patients will not consume meals during dialysis) and during the third week randomised subjects will cross over to the other study group. Every meal will provide 1/3 of daily recommended energy and protein intake (35 kcal/kg body weight/day, 0.7 gr protein/kg body weight/day for low protein meals and 1.5 gr protein/kg body weight/day for high protein meals). All the meals will be prepared in the hospital's kitchen and will be personalized to each patient's preferences. The meal will be given one hour after the start of the session and should be consumed completely during dialysis.
Patients will be evaluated for the following parameters during their midweek dialysis session:
- Intradialytic blood pressure
- 24-hour ambulatory blood pressure
- Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity, Augmentation Index)
- Hemodialysis adequacy
- Nutritional status
Intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). Urea reduction ratio (URR) and Kt/V (standard and equilibrated) will be used as measures for dialysis adequacy. Possible changes in patients nutritional status will be assessed using the Malnutrition-Inflammation Score (MIS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to have provided informed written consent
- •Patients undergoing maintenance hemodialysis for at least 3 months prior to enrollment
- •Ability to self-ingest food during the dialysis session
排除标准
- •History of malignancy or any other clinical condition associated with very poor prognosis
- •Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
- •Patients receiving parenteral nutrition
- •Body mass index (BMI) of >40 kg/m2
- •Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used as dialysis access
- •Patients with major amputations (eg lower limbs)
- •Women during pregnancy or lactation
- •Patients with unsuccessful 24-hour ambulatory recording of blood pressure with Mobil-O-Graph device, in accordance with the current European Society of Hypertension Guidelines.
结局指标
主要结局
Effect of meal versus no meal consumption during hemodialysis on intradialytic blood pressure
时间窗: 3 weeks
Meal consumption is expected to lower intradialytic blood pressure and increase hypotensive events during hemodialysis. Intradialytic blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany) during the midweek dialysis session.
Effect of high versus low protein meal consumption during dialysis on intradialytic blood pressure
时间窗: 3 weeks
High protein meals are expected to affect less intradialytic blood pressure than low protein meals. Intradialytic blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany) during the midweek dialysis session.
次要结局
- Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure(3 weeks)
- Effect of high versus low protein meals during dialysis on hemodialysis adequacy.(3 weeks)
- Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity(3 weeks)
- Effect of high versus low protein meals during dialysis on patients nutritional status(3 weeks)
- Effect of high versus low protein meal consumption during dialysis on Augmentation Index(3 weeks)
研究者
Vaios Vasileios
Vaios Vasileios, Resident in Nephrology, Department of Nephrology and Hypertension, AHEPA University Hospital, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki