Nocturnal Home Hemodialysis Draft Claudia C RuizZacharek M

Nocturnal Home Hemodialysis Draft Claudia C. Ruiz-Zacharek, M. D. Medical Officer / Nephrologist Gastroenterology and Renal Devices Branch

Overview 1. Background Information 2. Nocturnal Home Hemodialysis 3. Clinical Studies

Background Information § § Conventional Hemodialysis v typically in-center, 4 hours 3 X week v Patient has a passive role during treatment Nocturnal Home Hemodialysis v performed at home, typically at night, and while the patient sleeps. v Patient is the performer of the treatment

Data from the United States Renal Data System (USRDS) § Prevalence of patients on hemodialysis in the United States, 2002: 281, 594 § 0. 3% (843) home hemodialysis patients § 115 NHD patients in 13 centers in North America* * Lockridge, et. al. , Adv Ren Replace Ther 2001; 8(4): 250 -256.

Definitions and Nomenclature § Nocturnal Hemodialysis (NHD) v Nightly Hemodialysis v Nocturnal Home Hemodialysis § § In-center nocturnal hemodialysis, Long nocturnal hemodialysis Slow nocturnal hemodialysis, and Daily hemodialysis.

Definitions and Nomenclature (cont’d) Nocturnal Home Hemodialysis § § § Performed at home § Length is 6 -10 hours per night Absence of medical personnel Frequency has reportedly ranged from 57 nights a week

Definitions and Nomenclature (cont’d) Nocturnal Home Hemodialysis § Blood flows (QB) 200 -300 ml/min, § Dialysate flows (QD) usually ~300 ml/min, up to 800 ml/min* * Pierratos, A. Nephrol Dial Transplant 1999; 14: 2835 -2840

Definitions and Nomenclature (cont’d) § Human factors § Physician labeling § Patient labeling § Training

Definitions and Nomenclature (cont’d) Human Factors § the objective is to improve human performance § reduce the burden on training and labeling § reduce the likelihood of use error and patient injury

Definitions and Nomenclature (cont’d) Human Factors § The objective is to improve human performance § Reduce the burden on training and labeling § Reduce the likelihood of use error and patient injury

Definitions and Nomenclature (cont’d) Physician’s Instructions for Use § The manual that accompanies a medical device v v v indications for use statement, contraindications, precautions and warnings.

Definitions and Nomenclature (cont’d) Physician’s Instructions for Use § The manual that accompanies a medical device v v v indications for use statement, contraindications, precautions and warnings. § It should also include relevant data from clinical studies and instructions for using and caring for the device.

Definitions and Nomenclature (cont’d) Patient Instructions for Use § The manual that accompanies a medical device v v v indications for use statement, contraindications, precautions and warnings.

Definitions and Nomenclature (cont’d) Patient Instructions for Use § The manual that accompanies a medical device v v v indications for use statement, contraindications, precautions and warnings. § It should also include relevant data from clinical studies and instructions for using and caring for the device.

Definitions and Nomenclature (cont’d) Patient Instructions for Use § The manual that accompanies a medical device v v v indications for use statement, contraindications, precautions and warnings. § It should also include relevant data from clinical § studies and instructions for using and caring for the device. Written for a person with no medical training

Definitions and Nomenclature (cont’d) Training § Teaching provided by the manufacturer § Medical expert to train the lay user § Lay user to successfully use the device

Overview 1. Background Information 2. Nocturnal Home Hemodialysis 3. Clinical Studies

Overview 1. Background Information 2. Nocturnal Home Hemodialysis 3. Clinical Studies

Nocturnal Home Hemodialysis § Device design and Components § Human Factors Issues § Water Quality § Use of a Partner and Remote Monitoring § Vascular Access and Extracorporeal Circuit § § Connections Labeling Lay-user Training

Nocturnal Home Hemodialysis § Conventional Hemodialysis v Patient is passive recipient § Nocturnal Home Hemodialysis v Patient’s active role v Giver of treatment v Presumably asleep v troubleshooting

Nocturnal Home Hemodialysis Considerations for device design: § Redundancy § Additional safety alarms may become necessary v v v Loudness Sensitivity Ease of understanding and correction § User friendly

Nocturnal Home Hemodialysis Consider the following additional safety features: features § Safeguard to prevent blood access § § § disconnections or air emboli Type of vascular access Alarms to detect fluid leaks Moisture detector Software to include remote monitoring User-friendly instructions Displayed screen with menus

Nocturnal Home Hemodialysis Human Factors Issues § User-friendly § Dispose of devices safely and effectively with minimal dangerous error § Minimal dependance on labeling and training

Nocturnal Home Hemodialysis Water Quality concerns § Conventional hemodialysis: 360 L/week § Nocturnal Hemodialysis: 648 L 1080 L/week § Types of water treatment systems v Reverse osmosis (RO) v Deionization (DI) v Combination

Nocturnal Home Hemodialysis Water Quality concerns § Standard water quality for hemodialysis vs. higher standards § Type of water treatment system § Water source v v Municipal water suppliers Well water

Nocturnal Home Hemodialysis Issues on monitoring § § § Without a partner* In-center hemodialysis – constant monitoring Home hemodialysis * Raija, et. al. Experiences on Home Hemodialysis without an Assistant. Hemodialysis International 2003; 7(1): 73 -104.

Nocturnal Home Hemodialysis Issues on monitoring “Monitoring is essential for the initial 3 months of nocturnal HD therapy until the HD team is convinced the patient is stable and compliant. ” * The London Daily/Nocturnal Hemodialysis Study. AJKD, 2003

Nocturnal Home Hemodialysis Vascular access § Arteriovenous fistula § Synthetic graft § Long-term cuffed catheter

Nocturnal Home Hemodialysis Vascular access § Arteriovenous fistula § Synthetic graft § Long-term cuffed catheter

Nocturnal Home Hemodialysis Vascular access § § § Arteriovenous fistula* Synthetic graft Long-term cuffed catheter * Quintaliani, et. al. , Survival of vascular access during daily and three times a week hemodialysis. Clin Nephrol 2000; 53: 372 -377.

Nocturnal Home Hemodialysis § § § § Vascular access location Connection to the device Self cannulation Locking devices Enuresis alarms Moisture sensors Single vs dual needle technique

Nocturnal Home Hemodialysis Labeling § Operator’s Manual v v v Warnings Cautions and Precautions Device specifications Instructions for maintenance Cleaning and Disinfection § Patient Labeling § Physician’s Labeling § Additional risks

Nocturnal Home Hemodialysis Additional risks § Inadvertent disconnections § Blood loss from increased frequency of treatments § Potential increased rate of vascular access infection § Psychological effects

Nocturnal Home Hemodialysis Lay user training § § Conduct safe and effective NHD treatments Length of training reported to be approx 2 -8 weeks* φ * Agar, et. al. , Hemodialysis International 2003; 7(4): 278 -289. Φ Leitch, et. al. , Am J Kidney Dis 2003; 42(1): S 56 -60.

Nocturnal Home Hemodialysis Lay-user training § § Appropriate use of the hemodialysis device Interpretation and use of safety features, accessories and hemodialysis treatment itself

Nocturnal Home Hemodialysis Lay-user training § Water purification system § Catheter lock boxes § Moisture sensors § Monitoring device § Vascular access connection techniques § Test the adequacy of the training

Overview 1. Background Information 2. Nocturnal Home Hemodialysis 3. Clinical Studies

Overview 1. Background Information 2. Nocturnal Home Hemodialysis 3. Clinical Studies

Clinical Studies § Purpose § Patient selection § Study design

Clinical Studies Purpose To demonstrate the safety and effectiveness of the NHD devices under actual use conditions.

Clinical Studies FDA concerns: concerns § Outcomes § Clearance rates § Findings § Adverse events § Training

Clinical Studies Reported patient selection: §Agar , et. al. , Nocturnal Hemodialysis in Australia. Hemodialysis International 2003; 7(4): 278 -289. §Alloatti, et. al. , Long Nocturnal Dialysis. Blood Purif 2002; 20: 525 -530. §Covic, et. al. , Long-hours home haemodialysis – the best renal replacement therapy method? Q J Med 1999; 92: 251 -260.

Clinical Studies FDA concerns: § Patient selection for trial § Patient selection for marketing § Patient performs the entire treatment § Patient must wake up to attend the alarms

Clinical Studies Patient selection criteria: § Home environment v Water • • supply v Sewage v Electricity v Space v Social interaction Patient's vascular access type and location Availability of a partner Patient's compliance Psychological well being

Clinical Studies Study design: § Control group § Sample size § Length of follow up § Clinical endpoints § Evaluation of outcomes § Target patient population

Clinical Studies Other issues to be considered: § Dialysate composition and additives § Type of anticoagulation § Choice of dialyzer § Type of monitoring § Need of a partner § Vascular access § Reuse

Conclusion Nocturnal Home Hemodialysis Devices § Safety is a primary concern § Increased demands on patient and patient’s home/family should be assessed § Treatment may only be available to a selected population § Design of the clinical studies to demonstrate the safety and effectiveness of the device under actual use conditions should be discussed

References 1. United States Renal Data System (USRDS) www. usrds. org 2. Lockridge RS, Spencer M, Craft V, Pipkin M, Campbell D, Mc. Phatter L, Albert J, Anderson H, Jennings F, and Barger T. Nocturnal Home Hemodialysis in North America. Adv Ren Replace Ther 2001; 8(4): 250 -256. 3. Pierratos, A. Nocturnal home haemodialysis: an update on a 5 year experience. Nephrol Dial Transplant 1999; 14: 2835 -2840 4. Mehrabian S, Morgan D, Schlaeper C, Kortas C, and Lindsay RM. Equipment and water treatment considerations for the provision of quotidian home hemodialysis. Am J Kidney Dis 2003; 42: S 66 -S 70. 5. Raija M, Riitta MK, Meeri K, and Eero H. Experiences on Home Hemodialysis without an Assistant. Hemodialysis International 2003; 7(1): 73 -104.

References 6. Heidenheim AP, Leitch R, Kortas C and Lindsay RM. Patient Monitoring in the London Daily/Nocturnal Hemodialysis Study. Am J Kidney Dis 2003; 42: S 61 -S 65. 7. Quintaliani G, Buoncristiani U, Fagugli R, Kuluiranu H, Ciao G, Rondini L, Lowenthal DT, and Reboldi G. Survival of vascular access during daily and three times a week hemodialysis. Clin Nephrol 2000; 53: 372 -377. 8. Agar JWM, Somerville CA, Dwyer KM, Simmonds RE, Boddington JM, and Waldron CM. Nocturnal Hemodialysis in Australia. Hemodialysis International 2003; 7(4): 278 -289. Leitch R, Ouwendyk M, Ferguson E, Clement L, Peters K, Heidenheim AP, and Lindsay RM. Nursing Issues Related to Patient Selection, Vascular Access, and Education in Quotidian Hemodialysis. Am J Kidney Dis 2003; 42(1): S 56 -60.

References 10. Alloatti S, Molino A, Manes M, Bonfant G, and Pellu V. Long Nocturnal Dialysis. Blood Purif 2002; 20: 525 -530. 11. Covic A, Goldsmith DJA, Venning MC, and Ackrill P. Longhours home haemodialysis – the best renal replacement therapy method? Q J Med 1999; 92: 251 -260. 12. The following articles have not been cited in the above discussion of NHD, but may provide additional information. Copies of these may also be found in Appendix F. 13. Chan CT, Hanly P, Gabor J, Picton P, Pierratos A, and Floras JS. Nocturnal Hemodialysis Lowers Heart Rate during Sleep and Normalizes Its Parasympathetic and Sympathetic Modulation. Hemodialysis International 2003; 7(1): 73 -104.

References 14. Faratro R and Chan CT. Nocturnal Hemodialysis Improves Productivity of End-Stage Renal Failure Patients. Hemodialysis International, 2003; 7(1): 73 -104. 15. Francoeur R and Digiambatista A. Technical Considerations for Short Daily Home Hemodialysis and Nocturnal Home Hemodialysis. Adv Ren Replace Ther 2001; 8(4): 268 -272. 16. Heidenheim AP, Muirhead N, Moist L, and Lindsay RM. Patient Quality of Life on Quotidian Hemodialysis. Am J Kidney Dis 2003; 42: S 36 -S 41. 17. Kjellstrand CM and Ing T. Daily Hemodialysis: History and Revival of a Superior Dialysis Method. ASAIO Journal 1998; 117 -122.

References 18. Kjellstrand CM and Blagg CR. Differences in Dialysis Practice are the Main Reasons for the High Mortality Rate in the United States compared to Japan. Hemodialysis International 2003; 7(1): 67 -71. 19. Kroeker A, Clark WF, Heidenheim AP, Kuenzig L, Leitch R, Meyette M, Muirhead N, Ryan H, Welch R, White S, and Lindsay RM. An Operating Cost Comparison Between Conventional and Home Quotidian Hemodialysis. Am J Kidney Dis 2003; 42: S 49 -S 55. 20. Lindsay RM, Leitch R, Heidenheim AP, and Kortas C. The London Daily/Nocturnal Hemodialysis Study – Study Design, Morbidity, and Mortality Results. Am J Kidney Dis 2003; 42(1): S 5 -S 12.

References 21. Lindsay RM, Alhejaili F, Nesrallah G, Leitch R, Clement L, Heidenheim AP, and Kortas C. Calcium and Phosphate Balance with Quotidian Hemodialysis. Am J Kidney Dis 2003; 42, S 1: S 24 -29. 22. Nesrallah G, Suri R, Moist L, Kortas C, and Lindsay RM. Volume Control and Blood Pressure Management in Patients Undergoing Quotidian Hemodialysis. Am J Kidney Dis 2003; 42: S 13 -17. 23. Pierratos A. Daily nocturnal home hemodialysis. Kidney International 2004; 65: 1975 -1986. 24. Pierratos A. Quotidian Hemodialysis: Is it the Solution to the Problem? Seminars in Dialysis 2004; 17(2): 77 -78.

References 25. Radford MG, Shultman DS, Pasour AG, Cobb AM, and Chandler JT. An Incenter Nocturnal Hemodialysis Program – Three Years Experience. Hemodialysis International 2003; 7(1): 73 -104. 26. Rao M, Muirhead N, Klarenbach S, Moist L, and Lindsay RM. Management of Anemia with Quotidian Hemodialysis. Am J Kidney Dis 2003; 42: S 18 -S 23. 27. Spanner E, Suri R, Heidenheim AP, and Lindsay RM. The Impact of Quotidian Hemodialysis on Nutrition. Am J Kidney Dis 2003; 42(1): S 30 -S 35.

References 28. Suri R, Depner TA, Blake PG, Heidenheim AP, and Lindsay RM. Adequacy of Quotidian Hemodialysis. Am J Kidney Dis 2003; 42: S 42 -S 48. 29. Van Biesen W, Veys N, Vanholder R, and Lameire N. Effect of Long Nocturnal Dialysis on Nutritional Status and Blood Pressure Control. Hemodialysis International, 2003; 7(1): 73 -104. 30. Weick-Brady M. Medical Devices: Going Home. FDLI Update 2003; September/October: 23 -24, 2930.

References 31. Weinger MB, Foreword to Designing Usability into Medical Products 32. Woods JD, Port FK, Stannard D, Blagg CR, and Held PJ. Comparison of mortality with home hemodialysis and center hemodialysis: A national study. Kidney International, 1996; 49: 1464 -1470. 33. Young BA, Hynes J, and Mc. Comb T. Home Hemodialysis: Associations with Modality Failure. Hemodialysis International, 2003; 7: 73104.