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

NCT03947710 | Unknown

• 1 other identifier: MedAuth2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Effect of meal versus no meal consumption during hemodialysis on intradialytic blood pressure

  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.

  3 weeks

• Effect of high versus low protein meal consumption during dialysis on intradialytic blood pressure

  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.

  3 weeks

Secondary Outcomes (5)

• Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure

  3 weeks

• Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity

  3 weeks

• Effect of high versus low protein meal consumption during dialysis on Augmentation Index

  3 weeks

• Effect of high versus low protein meals during dialysis on hemodialysis adequacy.

  3 weeks

• Effect of high versus low protein meals during dialysis on patients nutritional status

  3 weeks

Study Arms (3)

High-protein meals

EXPERIMENTAL

Patients with End Stage Renal disease on maintenance hemodialysis will consume high protein meals during their dialysis sessions for one week.

Other: High-protein meals

Low-protein meals

EXPERIMENTAL

Patients with End Stage Renal disease on maintenance hemodialysis will consume low protein meals during their dialysis sessions for one week

Other: Low- protein meals

No meals

EXPERIMENTAL

Patients with End Stage Renal disease on maintenance hemodialysis will not consume meals during their dialysis sessions for one week

Other: No meals

Interventions

High-protein meals OTHER

Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)

High-protein meals

Low- protein meals OTHER

Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)

Low-protein meals

No meals OTHER

Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)

No meals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, Select A State/Province, 54636, Greece

RECRUITING

Related Publications (16)

• 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.

  PMID: 12164890 BACKGROUND

• 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.

  PMID: 12874743 BACKGROUND

• 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.

  PMID: 27659126 BACKGROUND

• 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.

  PMID: 7825766 BACKGROUND

• 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.

  PMID: 30107974 BACKGROUND

• 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.

  PMID: 25443543 BACKGROUND

• 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.

  PMID: 25322847 BACKGROUND

• 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.

  PMID: 11868999 BACKGROUND

• 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.

  PMID: 28032072 BACKGROUND

• 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.

  PMID: 21239186 BACKGROUND

• 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.

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  PMID: 7124671 BACKGROUND

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  PMID: 19864884 BACKGROUND

• 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.

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MeSH Terms

Conditions

Kidney Failure, Chronic; Kwashiorkor; Arteriosclerosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vassilios Liakopoulos, MD, PhD

  Department of Medicine, Aristotle University of Thessaloniki

  STUDY CHAIR

• Elena Fotiadou

  Department of Nutrition and Dietetics, AHEPA University Hospital, Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Vasileios Vaios, MD

CONTACT

+306984568904; vvaios_85@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vaios Vasileios, Resident in Nephrology, Department of Nephrology and Hypertension, AHEPA University Hospital, Aristotle University Of Thessaloniki

Model Details: Open label, randomized, cross-over clinical study.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)