NCT03947710

Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices

Acute Effect of Protein Intake During Dialysis on Intradialytic Blood Pressure, 24-hour Ambulatory Blood Pressure and Arterial Stiffness Indices in Maintenance Hemodialysis Patients.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• End Stage Renal Disease
• Hypotension During Dialysis
• Protein Malnutrition
• Arterial Sclerosis

Interventions

Type	Name	Description
OTHER	High-protein meals	Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
OTHER	Low- protein meals	Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
OTHER	No meals	Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2019-05-13
• Last updated: 2020-01-07

Locations

1 site across 1 country: Greece