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.
NCT number | NCT03947710 |
Other study ID # | MedAuth2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2019 |
Est. completion date | August 1, 2020 |
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Greece | AHEPA University Hospital | Thessaloniki | Select A State/Province |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Jansen RW, Lipsitz LA. Postprandial hypotension: epidemiology, pathophysiology, and clinical management. Ann Intern Med. 1995 Feb 15;122(4):286-95. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Sherman RA, Torres F, Cody RP. Postprandial blood pressure changes during hemodialysis. Am J Kidney Dis. 1988 Jul;12(1):37-9. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure | 24-hour blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). Measurement of 24-hour ambulatory blood pressure will start at the beginning of the midweek dialysis session for each group (high versus low protein meals during dialysis). | 3 weeks | |
Secondary | Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity | Pulse Wave Velocity will be measured for each group (high versus low protein meals) during the midweek dialysis session using the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). | 3 weeks | |
Secondary | Effect of high versus low protein meal consumption during dialysis on Augmentation Index | Augmentation Index will be measured for each group (high versus low protein meals) during the midweek dialysis session using the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). | 3 weeks | |
Secondary | Effect of high versus low protein meals during dialysis on hemodialysis adequacy. | Hemodialysis adequacy will be calculated for each patient group (high versus low protein meals) using the Urea reduction ratio (URR) and Kt/V (standard and equilibrated) for the midweek dialysis session. | 3 weeks | |
Secondary | Effect of high versus low protein meals during dialysis on patients nutritional status | Nutritional status will be calculated for each group (high versus low protein meals) using the Malnutrition-Inflammation Score (MIS). The Malnutrition-Inflamation score (MIS) is composed of 10 components which include: dry weight change over the last 3-6 months, current dietary intake, gastrointestinal symptoms, functional capacity (nutritionally related functional impairment), co-morbidity (including number of years on dialysis), decreased fat stores or loss of subcutaneous fat on physical examination (below eyes, triceps, biceps, chest), signs of muscle wasting (temple, clavicle, scapula, ribs, quadriceps, knee, interosseous), body mass index calculation, serum albumin levels, and serum total iron binding capacity. Each component of the MIS has 4 levels of severity, from 0 (normal) to 3 (severely abnormal). The sum of all 10 MIS components can range from 0 (normal) to 30 (severely malnourished); higher score reflects a more severe degree of malnutrition and inflammation. | 3 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04076488 -
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
|
N/A | |
Completed |
NCT03289650 -
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
|
Phase 3 | |
Completed |
NCT04042324 -
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01242904 -
Use of a Bimodal Solution for Peritoneal Dialysis
|
Phase 2 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03257410 -
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A | |
Withdrawn |
NCT02130817 -
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
|
Phase 4 | |
Completed |
NCT05540457 -
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
|
N/A | |
Not yet recruiting |
NCT04900610 -
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
|
N/A | |
Recruiting |
NCT02176434 -
Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease
|
N/A | |
Active, not recruiting |
NCT02581449 -
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
|
Phase 2 | |
Completed |
NCT02215655 -
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
|
N/A | |
Completed |
NCT02830490 -
Reliability of Functional Measures in Hemodialysis Patient.
|
N/A | |
Completed |
NCT02832466 -
Quantifying the Deterioration of Physical Function in Renal Patients
|
N/A | |
Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
Completed |
NCT02832440 -
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
|
N/A | |
Recruiting |
NCT01912001 -
Virtual Ward for Home Dialysis
|
N/A |