The Effect of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control in Children on Chronic Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Ultrafiltration efficiency
研究概览
简要总结
Fluid overload and hypertension are prevalent in children undergoing chronic peritoneal dialysis (PD), especially in low- and middle-income countries (LMICs). These complications often lead to increased hospitalizations, higher medication use, and, in some cases, conversion to hemodialysis. Icodextrin is used to enhance ultrafiltration (UF) and reduce glucose exposure, but its effectiveness in children with a single long dwell has been inconsistent. Preliminary observations suggest that shorter, twice-daily icodextrin exchanges may improve UF and blood pressure (BP) control. However, no randomized trial has evaluated this approach in pediatric patients.
详细描述
- Background and Rationale Fluid overload and hypertension are among the most prevalent and clinically significant complications in pediatric patients receiving chronic peritoneal dialysis (PD). In children, extracellular volume expansion contributes to left ventricular hypertrophy, increased arterial stiffness, impaired growth, and heightened cardiovascular morbidity and mortality. These complications are especially burdensome in low- and middle-income countries (LMICs), where limited access to automated PD, hemodialysis facilities, and antihypertensive medications leads to frequent hospitalizations, increased costs, and higher rates of dialysis modality switch.
Icodextrin is a glucose polymer solution used in PD as a glucose-sparing osmotic agent. Unlike glucose-based solutions that rely on crystalloid osmosis and are subject to rapid dissipation of the osmotic gradient, icodextrin provides sustained ultrafiltration (UF) through colloid osmosis. Its absorption via lymphatic pathways leads to more stable osmotic gradients, particularly during long dwell periods. However, pediatric studies show inconsistent results when icodextrin is used once daily in a single long daytime dwell, with some children demonstrating inadequate fluid removal and variable blood pressure (BP) control.
Emerging observational data and small pilot studies suggest that dividing the icodextrin dose into two separate exchanges per day (2-Ico) may improve ultrafiltration efficiency by maintaining a more consistent osmotic gradient throughout the 24-hour cycle. This approach may also reduce fluctuations in intravascular volume, improve BP stability, and enhance patient comfort. To date, however, no randomized controlled trial (RCT) has rigorously assessed the safety, efficacy, and tolerability of two daily icodextrin exchanges in the pediatric population.
This investigator-led multicenter randomized crossover trial addresses this evidence gap and aims to determine whether two daily icodextrin exchanges improve fluid status, BP control, and patient-related outcomes compared with a single daily icodextrin exchange in children on chronic PD. 2. Study Objectives
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 5-18 years of age
- •Receiving CAPD or CCPD for at least the preceding 4 weeks, and not likely to change from CAPD to CCPD during the study period
- •24-hour mean arterial pressure (MAP; measured by ambulatory blood pressure monitoring (ABPM) above the 95th percentile for age, sex, and height
- •24-hour urine output less than 200ml/day
排除标准
- •Children under 5 years of age (as younger children are more prone to hyponatremia)
- •Children with systolic BP < 50th centile for age, sex, and height in the preceding 4 weeks)
- •Children who are polyuric or those prone to hypotension (defined as > 2 episodes of systolic BP < 5th centile in the 4 weeks preceding the study)
- •Known allergy to starch
- •Pregnant women
- •Patients with maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis, uncorrectable mechanical defects that prevent effective PD or increase the risk of infection and documented loss of peritoneal function or extensive adhesions that compromise peritoneal function
研究组 & 干预措施
Group A (1-Ico)
Group A (One icodextrin exchange followed by two icodextrin exchanges)
干预措施: One icodextrin exchange (Drug)
Group A (1-Ico)
Group A (One icodextrin exchange followed by two icodextrin exchanges)
干预措施: Two icodextrin exchanges (Drug)
Group B (2-Ico)
Group B (Two icodextrin exchanges followed by one icodextrin exchange)
干预措施: One icodextrin exchange (Drug)
Group B (2-Ico)
Group B (Two icodextrin exchanges followed by one icodextrin exchange)
干预措施: Two icodextrin exchanges (Drug)
结局指标
主要结局
Ultrafiltration efficiency
时间窗: 12 weeks
Ultrafiltration (UF): Assessed clinically through blood pressure, presence of edema or crackles, reduced need for antihypertensive medications, residual kidney function, and mean daily UF.
The solute clearance adequacy
时间窗: 12 weeks
Toxin Removal: Evaluated by comparing pre- and post-intervention levels of electrolytes and urea clearance, calculated using the Kt/V formula.
次要结局
- To measure caregiver burden(12 weeks)
研究者
Sharon Teo
Consultant
National University Health System, Singapore