Cost-Utility of Conventional Hemodialysis (CHD) Vs Short Daily Hemodialysis (SDHD) for Patients Coming From Peritoneal Dialysis (HAPD/CAPD): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 31
- 主要终点
- mean quality-adjusted life year (QALY) score in the first year after the start of dialysis
研究概览
简要总结
The purpose of this randomized study is to determine if the home SDHD is a suitable alternative to conventional dialysis performed in a dialysis center for patients suffering from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD).
The adequacy of this alternative dialysis technique confirms that the SDHD at home is a viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of home SDHD compared with those of conventional dialysis: lowering blood pressure and lower use of antihypertensive drugs , improving the quality of life, maintenance of residual renal function related to a reduced risk of death and reduction in operating costs of dialysis and patient transport.
详细描述
Conventional Hemodialysis - 3 treatments per week for approximately 4 hours- will be performed in a dialysis clinic using any hemodialysis machine. Short Daily Hemodialysis - 5 or 6 treatments per week for approximately 2-4 hours per treatment- will be performed in the patient's home, using any hemodialysis machine. Partecipants randomized to SDHD will undergo an intensive home hemodialysis training program expected to take 2-6 weeks to complete. Qualified healthcare professionals will train each SDHD subject's partner to perform dialysis using any hemodialysis machine as chosen by clinicians. At baseline visit, before the first study treatment in either the SDHD or CHD arm, the following data will be collected: demographic information, ESRD history, EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, comorbid conditions, vascular access type, current medications. After hemodialysis start, patients will be followed up to 12 months with data collection at 1,3,6 and 12 months. At each visit, the following data will be collected: EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, adverse events, vascular access type, current medications. During this study, the following parameters will be strictly monitored: treatment costs, medications, number of hospitalization admissions, number of days in hospital and reasons for hospitalizations, additional costs informations.
Home hemodialysis could be an integrated therapeutic option favoring the de-hospitalization of patients requiring hemodialysis. Aim of this study is to offer the patient a better quality of life, to create the conditions for an improvement in blood pressure, phosphate control, of cardiovascular morbidity and mortality, and to reduce costs for the National Health Service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of end-stage renal disease
- •Currently performing Peritoneal Dialysis (HAPD and CAPD) for a minimum of 3 months.
- •Age 18 years or older.
- •Suitability for SDHD, determined on the basis of the following conditions:
- •willingness to be trained and perform frequent hemodialysis at home;
- •physically and mentally capable of performing frequent hemodialysis at home;
- •evaluation of the subject's home environment by a physician, training nurse and /or social worker;
- •a home dialysis partner willing to assist the participant in performing treatments at home;
- •agreement by a multidisciplinary (physician, nurse and any other professionals) team that the subject is suitable for SDHD.
- •Expected survival of at least one year.
- •Ability to understand and willingness to sign an informed consent statement.
排除标准
- •Current enrollment in another investigational drug or device trial which might impact the outcomes measures planned in this study.
- •Being scheduled for change of modality or plans to relocate to an area outside of the clinical center.
- •Pregnancy-lactation.
结局指标
主要结局
mean quality-adjusted life year (QALY) score in the first year after the start of dialysis
时间窗: one year
次要结局
- hospitalization rate (admissions and days(one year)
- dialysis related cost of care(one year)
- transportation costs per patient per year for the journeys "home-hospital-home"(one year)
- ratio nurse/patients(one year)
- systolic blood pressure and use of antihypertensive medications(one year)
- weekly standardized Kt/V delivered(one year)
- maintenance of residual renal function(one year)
- mineral metabolism, anemia parameters and nutritional parameters(one year)
研究者
Loreto GESUALDO
FULL PROFESSOR
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari