Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Children With End-stage Kidney Disease From Low-resource Settings

August 19, 2025 updated by: Sharon Teo, National University Health System, Singapore

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

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

To determine the ultrafiltration efficiency by measuring the following:
1. 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),
2. Change in the number of blood pressure medications before and after the intervention,
3. Absolute and relative fluid overload using bioimpedance analyzer (BIA),
4. Mean daily ultrafiltration (UF) or Total 24-h UF,
5. Residual kidney function: 24-hour urine output,
6. Glucose exposure
To determine the solute clearance adequacy by measuring the following:
1. Serum sodium, chloride, potassium, bicarbonate, serum albumin, calcium, and hemoglobin,
2. Phosphate clearance
3. Renal and peritoneal Kt/Vurea
4. Normalized protein catabolic rate (nPCR)
To measure caregiver burden using a Paediatric Renal Caregiver Burden Scale (PR-CBS).

Study Overview

Status

Recruiting

Conditions

Children on Chronic Peritoneal Dialysis

Intervention / Treatment

Detailed Description

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

To compare Modified CAPD (M-CAPD) and Conventional CAPD (C-CAPD) in terms of:

Clinical outcomes (ultrafiltration, solute clearance),
Resource utilization (waste reduction),
Caregiver burden. Specific Objectives
1. Ultrafiltration Efficiency i. Clinical parameters: BP, weight, edema, S3 gallop, lung crackles, tachycardia, tachypnea.
  ii. Number of antihypertensive medications. iii. Bioimpedance analysis (BIA). iv. Total 24-hour UF and residual urine output. v. Glucose exposure per day.
2. Solute Clearance Adequacy i. Serum electrolytes (Na, Cl, K, HCO₃-, Ca), albumin, hemoglobin. ii. Phosphate clearance. iii. Renal and peritoneal Kt/V. iv. Normalized protein catabolic rate (nPCR).
3. Caregiver Burden i. Measured using Pediatric Renal Caregiver Burden Scale (PR-CBS). Study Design
Design: Prospective, multicenter, randomized cross-over trial.
Duration: 12 weeks of active intervention per participant.
Setting: Pediatric dialysis centers in the Philippines, Malaysia, and Indonesia.
Run-in Period: 2 weeks
Intervention Phases: Each participant undergoes both C-CAPD and M-CAPD for 8 weeks total (2 months per arm), with a 2-week washout in between.
Randomization: Computer-generated random number assignment. Sample Size
Assuming high correlation (r=0.95), 26 patients at PGH are sufficient (13 per arm). Total across centers: 44 children aged 2 to ≤18 years.

Intervention Details Conventional CAPD (C-CAPD)

PD solutions: 1.5%, 2.5%, 4.25% dextrose
Fill volume: 1100-1400 mL/m²
3-4 exchanges per day
Day and night dwell times: 3-6 hours (day), 8-10 hours (night) Modified CAPD (M-CAPD)
Follows C-CAPD with addition of 1-2 short, low-volume (15-30 min) exchanges before full-volume dwell.
Short dwell volume comes from remaining solution in the 2L bag. Monitoring and Follow-Up
Every 2 weeks (remote or in-person)
Monitored parameters: BP, HR, weight, edema, UF, urine output
Data collection notebook maintained by patient/caregiver Adverse Events Monitoring

Includes:

Exit site infection
Peritonitis
Hypertension or fluid overload
Dehydration (over-UF)
Hyperglycemia
Hospitalization
Withdrawal criteria detailed Outcome Measures and Data Collection Timepoints: Baseline, post-randomization (6 weeks), post-crossover (12 weeks)

Data Collected:

Physical exam, vital signs, UF/urine output
Lab values: electrolytes, albumin, hemoglobin, FBS
Bioimpedance analysis
Kt/V, nPCR
PR-CBS for caregiver burden Data Analysis Plan
Descriptive statistics: for demographics and baseline data
Paired t-tests: for continuous outcomes
McNemar's test: for categorical outcomes (e.g., edema)
Outcomes compared within subjects (cross-over design) Ethical Considerations
Guidelines followed: Declaration of Helsinki, ISO 14155:2011, Good Clinical Practice, Philippine Data Privacy Act (2012)
Ethics approval: To be obtained from institutional ethics boards
Informed consent: Required from caregivers; assent from children ≥6 years Risks
Minor discomfort from added blood draws
No added infection risk from M-CAPD as procedure remains closed
Risks managed with prompt clinical support and compensation Benefits
Improved PD efficiency and fluid management
Reduced glucose exposure and complications
Less wastage of PD fluid
Cost savings for families
Enhanced caregiver education and burden reduction
Potential improvement in health-related quality of life Compensation
Covers: PD supplies, lab tests, transport, meals
Provides treatment for study-related injuries
Free antibiotics for PD-related infections Privacy and Confidentiality
Strict adherence to data protection guidelines
Anonymized data with unique identifiers
Secure physical and digital storage
Data access restricted to PI and trained assistant
All data deleted within 2 years of study conclusion Dissemination Plan
Results to be shared with physicians, caregivers, and published in peer-reviewed journals
All data anonymized in reports Intellectual Property and Legal Compliance
Pre-existing IP remains with originator
Jointly generated IP to be co-owned
Philippine laws and UP policies govern research conduct Vulnerable Populations
Pediatric patients with ESKD from lower socioeconomic backgrounds
Extra care in informed consent and ethical oversight

Study Type

Interventional

Enrollment (Estimated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sharon Teo, Consultant
Phone Number: +65 91678482
Email: sharon_teo@nuhs.edu.sg

Study Contact Backup

Name: Mya Than
Phone Number: +65 67722460
Email: than_mya@nuhs.edu.sg

Study Locations

Philippines
- Ermita
  - Manila, Ermita, Philippines, 1000 Metro Manila
    - Recruiting
    - Philippine General Hospital
    - Contact:
      
      Lourdes Paula R. Resontoc, MD
      
      Phone Number: +63 9178309796
      
      Email: lrresontoc@up.edu.ph
    - Principal Investigator:
      
      Lourdes Paula R. Resontoc, MG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

CKD 5D who have been on peritoneal dialysis for at least three months.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: C-CAPD Prescription 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. Other Names: M-CAPD Prescription Other: M-CAPD Prescription 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.
Experimental: 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.	Other: C-CAPD Prescription 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. Other Names: M-CAPD Prescription Other: M-CAPD Prescription 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.

Participant Group / Arm

Intervention / Treatment

Active Comparator: 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

Other: C-CAPD Prescription