End-Stage Renal Disease (ESRD) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 1. 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 2. 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) 3. To measure caregiver burden using a Paediatric Renal Caregiver Burden Scale (PR-CBS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Philippines
Philippine General Hospital
RECRUITING
Manila
Contact Information
Primary
Sharon Teo, Consultant
sharon_teo@nuhs.edu.sg
+65 91678482
Backup
Mya Than
than_mya@nuhs.edu.sg
+65 67722460
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 44
Treatments
Active_comparator: C-CAPD therapy
The prescription for the C-CAPD therapy is as follows:~1. PD solution containing 1.5%, 2.5% dextrose (or its equivalent, for example, 2.3%), 4.25%.~2. Full fill volume computed as 1100-1400 ml/m2 as described by Fischbach et al. \[19\],~3. Day-time and night-time dwell time ranging from 3 to 6 hours~4. Two to 3-daytime exchanges with or without night exchange~5. 8 to 10 hours of overnight dwell
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.
Sponsors
Leads: National University Health System, Singapore
Collaborators: Pediatric Institute, Hospital Kuala Lumpur, Hospital Tuanku Jaafar, Seremban, Negeri Sembilan, Dr. Soetomo General Hospital, University of the Philippines Manila - Philippine General Hospital

This content was sourced from clinicaltrials.gov