End Stage Renal Disease Clinical Trial
Official title:
Acute Effect of Protein Intake During Dialysis on Intradialytic Blood Pressure, 24-hour Ambulatory Blood Pressure and Arterial Stiffness Indices in Maintenance Hemodialysis Patients.
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.
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:
1. Intradialytic blood pressure
2. 24-hour ambulatory blood pressure
3. Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity,
Augmentation Index)
4. Hemodialysis adequacy
5. 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).
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