Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Skin sodium concentration
研究概览
简要总结
Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.
详细描述
Hypothesis
Interdialytic peritoneal ultrafiltration (iPUF) via Tenckhoff peritoneal dialysis catheter using 10% Dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent HD patients.
Overview: This is a prospective, interventional pilot study from the London Health Sciences Centre (LHSC) prevalent HD population. Study patients will undergo the surgical implantation of a Tenckhoff peritoneal dialysis catheter before study start. After the successful insertion of the Tenckhoff catheter, study patients will enter a run-in phase, where their residual renal function, volume, hemodynamic and cardiac status during HD will be assessed. During the following weeks (intervention weeks 1, 2, 3), study patients will receive in-center iPUF intervention, consisting of peritoneal infusate instillation of a 10% dextrose solution via a Tenckhoff catheter, immediately after the first two HD sessions of the week (Monday, Wednesday); the infusate will be dwelling in the study patient's peritoneal cavity for 2 hours, at the end of which the solution will be drained and the patient sent home. Study patients will be monitored during infusate administration and for the first four hours thereafter. The study intervention will be discontinued at the beginning of week 5 (Wash-out); during week 5 and the first HD session of week 6, study patients will be monitored to observe potential residual effects of the iPUF intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •At least one of the following:
- •Average per-session interdialytic weight gain ≥ 4.0 % of their dry weight in the last month;
- •Inability to consistently achieve dry weight with the current treatment schedule;
- •Need for additional HD treatments to achieve prescribed dry weight.
- •Weekly HD sessions - up to three times/week
- •Age ≥18 years
- •Willing and able to give informed consent
排除标准
- •Contraindications to peritoneal dialysis
- •Contraindications to MRI
- •Uncontrolled diabetes mellitus
- •Active infections
- •Non-compliance to hemodialysis prescription
- •Pre-study serum sodium < 130 mmol/L
研究组 & 干预措施
Interdialytic peritoneal ultrafiltration
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
干预措施: Interdialytic peritoneal ultrafiltration with 10% dextrose solution (Combination Product)
结局指标
主要结局
Skin sodium concentration
时间窗: End of week 4
Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
Adverse events
时间窗: iPUF interventions on Week 2, 3 and 4
Completion of the iPUF treatment without adverse events
次要结局
- Total weekly sodium removal with interdialytic peritoneal ultrafiltration(week 2, 3, 4)
- Interdialytic weight gain(week 1 vs 4, week 1 vs 5-6)
- Home blood pressure(week 1 vs week 4, week 1 vs 5-6)
- Changes in serum sodium(Through study completion, average of all study treatments)
- Total volume of fluid removed with interdialytic peritoneal ultrafiltration(week 2, 3, 4)
- Mean intradialytic hemodynamics(week 1 vs 4, week 1 vs 6)
- Regional wall motion abnormalities(week 1 vs 4, week 1 vs 6)
- Symptoms(week 1 vs 4, week 1 vs 6)
- Infusion pain(Through study completion, average of all study treatments)
研究者
Chris McIntyre
Professor of Medicine, Medical Biophysics and Pediatrics, School of Medicine and Dentistry, Western University; Director of The Kidney Clinical Research Unit, London Health Sciences Centre, London, ON, Canada
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's