The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty
NCT ID: NCT03663049
Last Updated: 2019-04-23
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
PHASE4
30 participants
INTERVENTIONAL
2018-08-17
2021-05-31
Brief Summary
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Detailed Description
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Previous clinical trials of statins only assessed the known adverse effects of statins such as abnormal liver function tests and acute kidney injury, adverse effects that occur rarely (\< 1%). Trials did not assess other side effects such as cognitive decline or muscle weakness that may be more common in older patients with kidney failure. The aim of this pilot study is to examine the potential side effects of statin medication use in older patients receiving dialysis by conducting a randomized pilot trial of a statin holiday (3 months of discontinuation) vs. no holiday and measuring changes in cognitive function, muscle strength, quality of life and frailty. The investigators hypothesize that measures of cognitive function, grip strength, quality of life and overall frailty will improve after 6 weeks of discontinuation of statins. After obtaining informed consent, patients will complete assessments of quality of life (SF-20), cognition, muscle strength and frailty at baseline and again at 6 and 12 weeks after statin holiday (intervention group) vs. no statin holiday (control group). All patients will resume statin medications after the 3 month trial. The overall goal is to determine whether changes in cognition, strength, frailty or quality of life can be measured using standard instruments. If changes can be detected, pilot data from this study will be used to design a larger trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual care
These patients will continue as statins as usual.
No interventions assigned to this group
Discontinue statin
Patients randomized to this group will stop using the statins they are currently prescribed and will not use their statin medication for 12 weeks.
discontinue statin
Discontinue statin as prescribed for 12 weeks
Interventions
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discontinue statin
Discontinue statin as prescribed for 12 weeks
Eligibility Criteria
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Inclusion Criteria
2. Receiving maintenance dialysis for at least 6 months,
3. Must be on a statin medication,
4. Receiving dialysis at the Loyola University Medical Center dialysis unit ,
5. Can be on hemodialysis or peritoneal dialysis,
Exclusion Criteria
2. Any recent hospital admission (within 2 weeks)
3. Recent dialysis start (within 6 months)
4. Any cancer diagnosis, with exception of innocuous skin cancers and previously treated cancers
5. Any recent (\< 1 year) solid organ transplant
6. Active on kidney transplant wait list
7. Recent acute coronary event (e.g. recent NSTEMI, stent, angioplasty, CABG) within 6 months
8. Non-English speaking
9. Diagnosis of dementia
10. Patients who are unable to provide informed consent
70 Years
ALL
No
Sponsors
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Loyola University
OTHER
Responsible Party
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Julia Schneider
Assistant Professor
Principal Investigators
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Julia Schneider
Role: PRINCIPAL_INVESTIGATOR
Loyola University Chicago
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Clark DA, Khan U, Kiberd BA, Turner CC, Dixon A, Landry D, Moffatt HC, Moorhouse PA, Tennankore KK. Frailty in end-stage renal disease: comparing patient, caregiver, and clinician perspectives. BMC Nephrol. 2017 May 2;18(1):148. doi: 10.1186/s12882-017-0558-x.
McIntyre C, McQuillan R, Bell C, Battistella M. Targeted Deprescribing in an Outpatient Hemodialysis Unit: A Quality Improvement Study to Decrease Polypharmacy. Am J Kidney Dis. 2017 Nov;70(5):611-618. doi: 10.1053/j.ajkd.2017.02.374. Epub 2017 Apr 14.
St Peter WL. Management of Polypharmacy in Dialysis Patients. Semin Dial. 2015 Jul-Aug;28(4):427-32. doi: 10.1111/sdi.12377. Epub 2015 Apr 9.
Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.
Holdaas H, Holme I, Schmieder RE, Jardine AG, Zannad F, Norby GE, Fellstrom BC; AURORA study group. Rosuvastatin in diabetic hemodialysis patients. J Am Soc Nephrol. 2011 Jul;22(7):1335-41. doi: 10.1681/ASN.2010090987. Epub 2011 May 12.
Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.
Olyaei A, Steffl JL, MacLaughlan J, Trabolsi M, Quadri SP, Abbasi I, Lerma E. HMG-CoA reductase inhibitors in chronic kidney disease. Am J Cardiovasc Drugs. 2013 Dec;13(6):385-98. doi: 10.1007/s40256-013-0041-4.
Wanner C, Tonelli M; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. Kidney Int. 2014 Jun;85(6):1303-9. doi: 10.1038/ki.2014.31. Epub 2014 Feb 19.
Manley HJ, McClaran ML, Overbay DK, Wright MA, Reid GM, Bender WL, Neufeld TK, Hebbar S, Muther RS. Factors associated with medication-related problems in ambulatory hemodialysis patients. Am J Kidney Dis. 2003 Feb;41(2):386-93. doi: 10.1053/ajkd.2003.50048.
Talar Markossian, Holly Kramer, Nicholas Burge, et a. Utilization of statins in U.S. Veterans with dialysis-dependent chronic kidney disease. Health Sciences Research. 2018 Under review
Kurella Tamura M, Larive B, Unruh ML, Stokes JB, Nissenson A, Mehta RL, Chertow GM; Frequent Hemodialysis Network Trial Group. Prevalence and correlates of cognitive impairment in hemodialysis patients: the Frequent Hemodialysis Network trials. Clin J Am Soc Nephrol. 2010 Aug;5(8):1429-38. doi: 10.2215/CJN.01090210. Epub 2010 Jun 24.
Johansen KL, Chertow GM, Jin C, Kutner NG. Significance of frailty among dialysis patients. J Am Soc Nephrol. 2007 Nov;18(11):2960-7. doi: 10.1681/ASN.2007020221. Epub 2007 Oct 17. No abstract available.
Herzog CA, Asinger RW, Berger AK, Charytan DM, Diez J, Hart RG, Eckardt KU, Kasiske BL, McCullough PA, Passman RS, DeLoach SS, Pun PH, Ritz E. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2011 Sep;80(6):572-86. doi: 10.1038/ki.2011.223. Epub 2011 Jul 13.
Isoyama N, Qureshi AR, Avesani CM, Lindholm B, Barany P, Heimburger O, Cederholm T, Stenvinkel P, Carrero JJ. Comparative associations of muscle mass and muscle strength with mortality in dialysis patients. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1720-8. doi: 10.2215/CJN.10261013. Epub 2014 Jul 29.
Dong J, Pi HC, Xiong ZY, Liao JL, Hao L, Liu GL, Ren YP, Wang Q, Duan LP, Zheng ZX. Depression and Cognitive Impairment in Peritoneal Dialysis: A Multicenter Cross-sectional Study. Am J Kidney Dis. 2016 Jan;67(1):111-8. doi: 10.1053/j.ajkd.2015.06.025. Epub 2015 Aug 6.
Fazekas G, Fazekas F, Schmidt R, Kapeller P, Offenbacher H, Krejs GJ. Brain MRI findings and cognitive impairment in patients undergoing chronic hemodialysis treatment. J Neurol Sci. 1995 Dec;134(1-2):83-8. doi: 10.1016/0022-510x(95)00226-7.
Sehgal AR, Grey SF, DeOreo PB, Whitehouse PJ. Prevalence, recognition, and implications of mental impairment among hemodialysis patients. Am J Kidney Dis. 1997 Jul;30(1):41-9. doi: 10.1016/s0272-6386(97)90563-1.
Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, Mapes DL, Vanholder RC, Hasegawa T, Robinson BM, Pisoni RL. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1702-12. doi: 10.2215/CJN.12371213. Epub 2014 Oct 2.
Topolski TD, LoGerfo J, Patrick DL, Williams B, Walwick J, Patrick MB. The Rapid Assessment of Physical Activity (RAPA) among older adults. Prev Chronic Dis. 2006 Oct;3(4):A118. Epub 2006 Sep 15.
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Related Links
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Drug Safety and Availability - FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs \[Internet\].: Center for Drug Evaluation and Research \[cited Mar 9, 2018\]
Other Identifiers
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210890
Identifier Type: -
Identifier Source: org_study_id
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