A Multicenter Study Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Delivering High Quality Goal-directed Peritoneal Dialysis in Children With End-stage Kidney Disease From Low-resource Settings: MaxED-OUT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Ultrafiltration efficiency
研究概览
简要总结
This study aims to compare modified CAPD (M-CAPD) and conventional CAPD (C-CAPD) in terms of delivering high-quality, goal-directed PD as well as avoiding resource wastage in prevalent ESKD patients aged 2 to ≤18 years using a randomized cross-over study design for one year.
This study hypothesizes that M-CAPD will have better ultrafiltration and solute clearance than C-CAPD.
Specific objectives
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To determine the ultrafiltration efficiency by measuring the following:
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Clinical parameters: blood pressure, weight, evidence of fluid overload by the presence of edema, abnormal heart sounds (S3 gallop), lung crackles or rales, increased heart rate (tachycardia), rapid breathing (tachypnea),
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Change in the number of blood pressure medications before and after the intervention,
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Absolute and relative fluid overload using bioimpedance analyzer (BIA),
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Mean daily ultrafiltration (UF) or Total 24-h UF,
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Residual kidney function: 24-hour urine output,
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Glucose exposure
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To determine the solute clearance adequacy by measuring the following:
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Serum sodium, chloride, potassium, bicarbonate, serum albumin, calcium, and hemoglobin,
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Phosphate clearance
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Renal and peritoneal Kt/Vurea
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Normalized protein catabolic rate (nPCR)
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To measure caregiver burden using a Paediatric Renal Caregiver Burden Scale (PR-CBS).
详细描述
Background and Rationale Peritoneal dialysis (PD) is the primary kidney replacement therapy (KRT) for children with end-stage kidney disease (ESKD), particularly in low-resource settings. In these settings, continuous ambulatory peritoneal dialysis (CAPD) is more accessible than automated PD (APD) or hemodialysis due to the lack of power and expensive machinery.
However, standard CAPD regimens can lead to significant wastage of PD fluid. For example, using standard 2-liter bags, children often use only a portion of each bag, discarding the rest. Additionally, fixed-volume, fixed-dwell CAPD is often suboptimal for solute clearance and ultrafiltration, particularly in patients with different peritoneal membrane transport types.
Adapted APD (aAPD), pioneered by Fischbach et al., offers a better solution by combining short, low-volume exchanges with longer, high-volume ones to improve ultrafiltration and solute clearance. This study proposes a Modified CAPD (M-CAPD) that incorporates the principles of aAPD but adapted for manual (non-automated) settings.
Rationale No existing studies have applied the aAPD approach to CAPD in children or adults. This study addresses both clinical effectiveness and resource optimization in PD for children in Southeast Asia.
General 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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD 5D who have been on peritoneal dialysis for at least three months.
排除标准
- •Patients with BSA of ≥1.5 m2,
- •Evidence of mechanical causes of low ultrafiltration capacity (hernia, peri-catheter, or genital leaks, pleuroperitoneal communication),
- •Peritoneal membrane failure (encapsulating peritoneal sclerosis),
- •Recent episode of peritonitis (within two months)
- •Those who have been on hemodialysis before switching to PD in the last three weeks.
研究组 & 干预措施
C-CAPD therapy
The prescription for the C-CAPD therapy is as follows:
- PD solution containing 1.5%, 2.5% dextrose (or its equivalent, for example, 2.3%), 4.25%.
- Full fill volume computed as 1100-1400 ml/m2 as described by Fischbach et al. [19],
- Day-time and night-time dwell time ranging from 3 to 6 hours
- Two to 3-daytime exchanges with or without night exchange
- 8 to 10 hours of overnight dwell
干预措施: C-CAPD Prescription (Other)
C-CAPD therapy
The prescription for the C-CAPD therapy is as follows:
- PD solution containing 1.5%, 2.5% dextrose (or its equivalent, for example, 2.3%), 4.25%.
- Full fill volume computed as 1100-1400 ml/m2 as described by Fischbach et al. [19],
- Day-time and night-time dwell time ranging from 3 to 6 hours
- Two to 3-daytime exchanges with or without night exchange
- 8 to 10 hours of overnight dwell
干预措施: M-CAPD Prescription (Other)
M-CAPD Therapy
The prescription for the M-CAPD therapy is the C-CAPD with an additional 1 to 2 short, low-volume, 15 to 30-minute dwells per exchange before instilling the computed full dwell volume.
干预措施: C-CAPD Prescription (Other)
M-CAPD Therapy
The prescription for the M-CAPD therapy is the C-CAPD with an additional 1 to 2 short, low-volume, 15 to 30-minute dwells per exchange before instilling the computed full dwell volume.
干预措施: M-CAPD Prescription (Other)
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