Renal replacement treatment initiation with twice-weekly versus thrice-weekly haemodialysis in patients with incident dialysis-dependent kidney disease: rationale and design of the TWOPLUS pilot clinical trial
| العنوان: | Renal replacement treatment initiation with twice-weekly versus thrice-weekly haemodialysis in patients with incident dialysis-dependent kidney disease: rationale and design of the TWOPLUS pilot clinical trial |
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| المؤلفون: | Hiba I Sheikh, Kamyar Kalantar-Zadeh, Gregory B. Russell, Deanna N. Jones, Alison J. Fletcher, Shahriar Moossavi, Mariana Murea |
| المصدر: | BMJ open, vol 11, iss 5 BMJ Open, Vol 11, Iss 5 (2021) BMJ Open |
| بيانات النشر: | eScholarship, University of California, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Kidney Disease, kidney & urinary tract disorders, medicine.medical_treatment, Left, 030232 urology & nephrology, 030204 cardiovascular system & hematology, Kidney, Ventricular Function, Left, Urine collection device, Kidney Failure, chemistry.chemical_compound, 0302 clinical medicine, Medicine, Ventricular Function, Chronic, Renal Medicine, Acute kidney injury, Patiromer, General Medicine, Treatment Outcome, 6.1 Pharmaceuticals, Public Health and Health Services, Kidney Diseases, Patient Safety, medicine.medical_specialty, Adolescent, Clinical Trials and Supportive Activities, Clinical Sciences, Renal and urogenital, Renal function, end stage renal failure, 03 medical and health sciences, Rare Diseases, Clinical Research, Renal Dialysis, Internal medicine, North Carolina, Humans, Pandemics, Dialysis, Other Medical and Health Sciences, business.industry, SARS-CoV-2, Prevention, Evaluation of treatments and therapeutic interventions, COVID-19, Stroke Volume, medicine.disease, Clinical trial, Regimen, chemistry, Kidney Failure, Chronic, dialysis, business, Kidney disease |
| الوصف: | Introduction The optimal haemodialysis (HD) prescription—frequency and dose—for patients with incident dialysis-dependent kidney disease (DDKD) and substantial residual kidney function (RKF)—that is, renal urea clearance ≥2 mL/min/1.73 m2 and urine volume ≥500 mL/day—is not known. The aim of the present study is to test the feasibility and safety of a simple, reliable prescription of incremental HD in patients with incident DDKD and RKF. Methods and analysis This parallel-group, open-label randomised pilot trial will enrol 50 patients from 14 outpatient dialysis units. Participants will be randomised (1:1) to receive twice-weekly HD with adjuvant pharmacological therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or outright thrice-weekly HD (standard HD group). Age ≥18 years, chronic kidney disease progressing to DDKD and urine output ≥500 mL/day are key inclusion criteria; patients with left ventricular ejection fraction Ethics and dissemination The study has been reviewed and approved by the Institutional Review Board of Wake Forest School of Medicine in North Carolina, USA. Patient recruitment began on 14 June 2019, was paused between 13 March 2020 and 31 May 2020 due to COVID-19 pandemic, resumed on 01 June 2020 and will last until the required sample size has been attained. Participants will be followed in usual care fashion for a minimum of 6 months from last individual enrolled. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki. Trial registration number NCT03740048; Pre-results. |
| وصف الملف: | application/pdf |
| تدمد: | 0374-0048 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b7458cb4ada65915bf0a22529efbeac https://escholarship.org/uc/item/3r10d55p |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....1b7458cb4ada65915bf0a22529efbeac |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 03740048 |
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