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Proof of Concept of Adapted PD in Children (PC-AAPD)

NCT02748733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-05-08

No results posted yet for this study

Summary

The purpose of this study is to validate the concept of adapted automated PD a modified Peritoneal Equilibration Test (PET), will be performed in children on chronic PD. Instead of a single 4 hour standard dwell, two double mini PET using the same type and total volume of dialysate and the same total dwell time (150min) will be performed in randomised sequence. An double mini test consists of two identical dwells, reflecting routine PD, the other one of a short small dwell followed by a long, large dwell as suggested from adapted PD regimes successfully applied in adult PD patients.

Conditions

  • Primary Study Outcome: Sodium Clearance in Dialysis
  • Solute Removal
  • Ultrafiltration

Interventions

OTHER

Adapted double mini PET

The modified double mini PET mimics the treatment of adapted PD and thus allows its validation

OTHER

Standard double mini PET

The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • Hôpital de Hautepierre

    collaborator OTHER

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Claus P Schmitt, MD · Center for Pediatric and Adolescent Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-10-31
Completion
2018-01-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748733 on ClinicalTrials.gov