Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices
NCT ID: NCT03947710
Last Updated: 2020-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2019-08-01
2020-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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High-protein meals
Patients with End Stage Renal disease on maintenance hemodialysis will consume high protein meals during their dialysis sessions for one week.
High-protein meals
Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
Low-protein meals
Patients with End Stage Renal disease on maintenance hemodialysis will consume low protein meals during their dialysis sessions for one week
Low- protein meals
Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
No meals
Patients with End Stage Renal disease on maintenance hemodialysis will not consume meals during their dialysis sessions for one week
No meals
Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)
Interventions
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High-protein meals
Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
Low- protein meals
Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
No meals
Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing maintenance hemodialysis for at least 3 months prior to enrollment
* Ability to self-ingest food during the dialysis session
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Vaios Vasileios
Vaios Vasileios, Resident in Nephrology, Department of Nephrology and Hypertension, AHEPA University Hospital, Aristotle University Of Thessaloniki
Principal Investigators
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Vassilios Liakopoulos, MD, PhD
Role: STUDY_CHAIR
Department of Medicine, Aristotle University of Thessaloniki
Elena Fotiadou
Role: STUDY_DIRECTOR
Department of Nutrition and Dietetics, AHEPA University Hospital, Thessaloniki
Locations
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AHEPA University Hospital
Thessaloniki, Select A State/Province, Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
Burrowes JD, Larive B, Cockram DB, Dwyer J, Kusek JW, McLeroy S, Poole D, Rocco MV; Hemodialysis (HEMO) Study Group. Effects of dietary intake, appetite, and eating habits on dialysis and non-dialysis treatment days in hemodialysis patients: cross-sectional results from the HEMO study. J Ren Nutr. 2003 Jul;13(3):191-8. doi: 10.1016/s1051-2276(03)00069-4.
Rhee CM, You AS, Koontz Parsons T, Tortorici AR, Bross R, St-Jules DE, Jing J, Lee ML, Benner D, Kovesdy CP, Mehrotra R, Kopple JD, Kalantar-Zadeh K. Effect of high-protein meals during hemodialysis combined with lanthanum carbonate in hypoalbuminemic dialysis patients: findings from the FrEDI randomized controlled trial. Nephrol Dial Transplant. 2017 Jul 1;32(7):1233-1243. doi: 10.1093/ndt/gfw323.
Jansen RW, Lipsitz LA. Postprandial hypotension: epidemiology, pathophysiology, and clinical management. Ann Intern Med. 1995 Feb 15;122(4):286-95. doi: 10.7326/0003-4819-122-4-199502150-00009.
Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.
Kistler B, Benner D, Burgess M, Stasios M, Kalantar-Zadeh K, Wilund KR. To eat or not to eat-international experiences with eating during hemodialysis treatment. J Ren Nutr. 2014 Nov;24(6):349-52. doi: 10.1053/j.jrn.2014.08.003. Epub 2014 Oct 22.
Sarafidis PA, Georgianos PI, Karpetas A, Bikos A, Korelidou L, Tersi M, Divanis D, Tzanis G, Mavromatidis K, Liakopoulos V, Zebekakis PE, Lasaridis A, Protogerou AD. Evaluation of a novel brachial cuff-based oscillometric method for estimating central systolic pressure in hemodialysis patients. Am J Nephrol. 2014;40(3):242-50. doi: 10.1159/000367791. Epub 2014 Oct 11.
San Juan Miguelsanz M, Pilar SM, Santos de Pablos MR. Reduction of Kt/V by food intake during haemodialysis. EDTNA ERCA J. 2001 Jul-Sep;27(3):150-2. doi: 10.1111/j.1755-6686.2001.tb00165.x.
Borzou SR, Mahdipour F, Oshvandi K, Salavati M, Alimohammadi N. Effect of Mealtime During Hemodialysis on Patients' Complications. J Caring Sci. 2016 Dec 1;5(4):277-286. doi: 10.15171/jcs.2016.029. eCollection 2016 Dec.
Bossola M, Luciani G, Rosa F, Tazza L. Appetite and gastrointestinal symptoms in chronic hemodialysis patients. J Ren Nutr. 2011 Nov;21(6):448-54. doi: 10.1053/j.jrn.2010.09.003. Epub 2011 Jan 15.
Sherman RA, Torres F, Cody RP. Postprandial blood pressure changes during hemodialysis. Am J Kidney Dis. 1988 Jul;12(1):37-9. doi: 10.1016/s0272-6386(88)80069-6.
Heymsfield SB, McManus C, Smith J, Stevens V, Nixon DW. Anthropometric measurement of muscle mass: revised equations for calculating bone-free arm muscle area. Am J Clin Nutr. 1982 Oct;36(4):680-90. doi: 10.1093/ajcn/36.4.680.
Frisancho AR. New norms of upper limb fat and muscle areas for assessment of nutritional status. Am J Clin Nutr. 1981 Nov;34(11):2540-5. doi: 10.1093/ajcn/34.11.2540.
Durnin JV, Womersley J. Body fat assessed from total body density and its estimation from skinfold thickness: measurements on 481 men and women aged from 16 to 72 years. Br J Nutr. 1974 Jul;32(1):77-97. doi: 10.1079/bjn19740060. No abstract available.
Malindretos P, Sarafidis P, Spaia S, Sioulis A, Zeggos N, Raptis V, Kitos V, Koronis C, Kabouris C, Zili S, Grekas D. Adaptation and validation of the Kidney Disease Quality of Life-Short Form questionnaire in the Greek language. Am J Nephrol. 2010;31(1):9-14. doi: 10.1159/000252926. Epub 2009 Oct 26.
Agarwal R, Georgianos P. Feeding during dialysis-risks and uncertainties. Nephrol Dial Transplant. 2018 Jun 1;33(6):917-922. doi: 10.1093/ndt/gfx195.
Other Identifiers
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MedAuth2
Identifier Type: -
Identifier Source: org_study_id
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