Volume,Sodium and Blood Pressure Management in HD

NCT01766882 | Completed

• 1 other identifier: HUM00054879
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study to conduct a pilot, randomized trial in stable HD patients to evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight, combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure on hydration/volume status and blood pressure (BP) control.

Conditions

End Stage Renal Failure

Keywords

Hemodialysis; Blood Pressure; Hydration Status; Low-sodium diet

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Change in blood pressure (pre-dialysis in-center blood pressure readings, ABPM and home BP monitoring)

  Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days

Secondary Outcomes (12)

• Post-dialysis Weight

  12weeks

• Heart Rate

  12 weeks

• Plasma Volume

  12 Weeks

• Medication Use

  12 Weeks

• Interdialytic Weight gain

  12 Weeks

Study Arms (2)

Treatment

EXPERIMENTAL

1. Lower sodium intervention: Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day Lower dialysate sodium at 137 mmol/L. 2. Progressive Challenge to Post Dialysis Weight: The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments.

Behavioral: Lower sodium intervention; Other: Progressive Challenge to Post Dialysis Weight

Control

NO INTERVENTION

Usual care in addition to Blood pressure monitoring and and Hydration status monitoring

Interventions

Lower sodium intervention BEHAVIORAL

1\. Lower sodium intervention: 1. Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day (approximately \>180-200mmol/day in the average American diet). Sodium restriction will be implemented using intensive dietary counseling performed weekly by a registered study dietitian using the motivational interviewing technique. 2. Lower dialysate sodium at 137 mmol/L, if perchance a different concentration of dialysate is used for the enrolled individual, although this is unlikely in both the UM associated units, where for some time now, dialysate concentration of 137 mmol/L is currently being used as standard practice. Investigators will ensure that this sodium concentration is indeed used for all study participants.

Treatment

Progressive Challenge to Post Dialysis Weight OTHER

The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments, unless clinical evidence of volume depletion or hypotension precludes this challenge in the intervention arm. To avoid the occurrence of intradialytic hypotension, the ultrafiltration rate shall not exceed15 ml/kg/hour and post dialysis weight will not be reduced by more than 0.5 kg per dialysis session. In some patients, this may warrant prolongation of the treatment time to achieve lowering of target post dialysis weight, and this process of target weight reduction may need to continue up to and through the interim assessment phase (6-8 weeks).

Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable adult HD patient (age 18-85 years)
• Able and willing to adhere to study protocol

You may not qualify if:

• Recent acute illness (≤1month)
• Recent hospitalization (≤1month)
• Any psychological condition that could interfere with compliance with study protocol.
• Amputation of both lower limbs (due to interference with electric current for BIA measurement)
• Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings), if their presence interfere with appropriate measurements. In such patients consideration will be given to only doing the calf-BIA measurements and not the total body, at the discretion of the investigators.
• Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
• Pregnancy or lactation (pregnancy test will be applied only if the patient is in the reproductive age range).
• Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study

Sponsors & Collaborators

• University of Michigan: lead
• Renal Research Institute: collaborator

Study Sites (2)

University Dialysis Unit

Ann Arbor, Michigan, 48104, United States

Location

University of Michigan Dialyisis Unit

Livonia, Michigan, 48152, United States

Location

Related Publications (16)

• Charra B. Fluid balance, dry weight, and blood pressure in dialysis. Hemodial Int. 2007 Jan;11(1):21-31. doi: 10.1111/j.1542-4758.2007.00148.x.

  PMID: 17257351 BACKGROUND

• Nanovic L. Electrolytes and fluid management in hemodialysis and peritoneal dialysis. Nutr Clin Pract. 2005 Apr;20(2):192-201. doi: 10.1177/0115426505020002192.

  PMID: 16207656 BACKGROUND

• Aybal Kutlugun A, Erdem Y, Okutucu S, Yorgun H, Atalar E, Arici M. Effects of lowering dialysate sodium on flow-mediated dilatation in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Nov;26(11):3678-82. doi: 10.1093/ndt/gfr092. Epub 2011 Mar 18.

  PMID: 21421595 BACKGROUND

• Munoz Mendoza J, Bayes LY, Sun S, Doss S, Schiller B. Effect of lowering dialysate sodium concentration on interdialytic weight gain and blood pressure in patients undergoing thrice-weekly in-center nocturnal hemodialysis: a quality improvement study. Am J Kidney Dis. 2011 Dec;58(6):956-63. doi: 10.1053/j.ajkd.2011.06.030. Epub 2011 Aug 27.

  PMID: 21875769 BACKGROUND

• Manlucu J, Gallo K, Heidenheim PA, Lindsay RM. Lowering postdialysis plasma sodium (conductivity) to increase sodium removal in volume-expanded hemodialysis patients: a pilot study using a biofeedback software system. Am J Kidney Dis. 2010 Jul;56(1):69-76. doi: 10.1053/j.ajkd.2009.12.037. Epub 2010 Mar 19.

  PMID: 20303632 BACKGROUND

• Ritz E, Dikow R, Morath C, Schwenger V. Salt--a potential 'uremic toxin'? Blood Purif. 2006;24(1):63-6. doi: 10.1159/000089439.

  PMID: 16361843 BACKGROUND

• Maruyama C. Improvement of Threshold-Dosage Salt Sensitivity Strips in Evaluating Reduced Salt Diets. The Japanese Journal of Nutrition and Dietetics 1988;46:211-6.

  BACKGROUND

• Maruyama C. On Salt Taste Sensitivity of Healthy Patients and Patients with High Blood Pressure (Part 2). The Japanese Journal of Nutrition and Dietetics 1990;48:267-71.

  BACKGROUND

• Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.

  PMID: 15458464 BACKGROUND

• McCarley P. Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. Nephrol Nurs J. 2009 Jul-Aug;36(4):409-13.

  PMID: 19715108 BACKGROUND

• Sinha AD, Light RP, Agarwal R. Relative plasma volume monitoring during hemodialysis AIDS the assessment of dry weight. Hypertension. 2010 Feb;55(2):305-11. doi: 10.1161/HYPERTENSIONAHA.109.143974. Epub 2009 Dec 28.

  PMID: 20038754 BACKGROUND

• Kurtz TW, Griffin KA, Bidani AK, Davisson RL, Hall JE; Subcommittee of Professional and Public Education of the American Heart Association. Recommendations for blood pressure measurement in humans and experimental animals. Part 2: Blood pressure measurement in experimental animals: a statement for professionals from the subcommittee of professional and public education of the American Heart Association council on high blood pressure research. Hypertension. 2005 Feb;45(2):299-310. doi: 10.1161/01.HYP.0000150857.39919.cb. Epub 2004 Dec 20.

  PMID: 15611363 BACKGROUND

• Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.

  PMID: 15611362 BACKGROUND

• Urbina E, Alpert B, Flynn J, Hayman L, Harshfield GA, Jacobson M, Mahoney L, McCrindle B, Mietus-Snyder M, Steinberger J, Daniels S; American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee. Ambulatory blood pressure monitoring in children and adolescents: recommendations for standard assessment: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the council on cardiovascular disease in the young and the council for high blood pressure research. Hypertension. 2008 Sep;52(3):433-51. doi: 10.1161/HYPERTENSIONAHA.108.190329. Epub 2008 Aug 4. No abstract available.

  PMID: 18678786 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Ware J, Snow K K, Kosnski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: Health Institute, 1993.

  BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Rajiv Saran, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Internal Medicine/ Associate Director, Kidney Epidemiology & Cost Center

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 11, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

US (2)