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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02748733
• Date of registration: 13/04/2016
• Prospective Registration: No
• Primary sponsor: Heidelberg University
• Public title: Proof of Concept of Adapted PD in Children (PC-AAPD) PC-AAPD
• Scientific title: Randomized Cross-over Comparison of Double Mini PET With Standard vs. Adapted Dwell Volume and Dwell Time - Proof of Concept of Adapted PD
• Date of first enrolment: April 2016
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02748733
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Claus P Schmitt, MD
• Affiliation: Center for Pediatric and Adolescent Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- PD patients 5-21 years of age

- Stable PD

- Last peritonitis > 4 weeks ago

Exclusion Criteria:

- Polyuria and dehydrated patients (as to the clinical status RR, HR and BCM) not
allowing for more than 1.5% glucose content of PD fluid

- Hypoalbuminemia (serum albumin < 25g/l)

- Relevant changes in dialysis regime and diet the three days preceding the study

- Hb < 9 mg/dl

- Pregnancy

- History of repeated hernia or PD fluid leakage

- Intolerability of intraperitoneal pressure of up to 18 cm H2O at 1400ml/m²

- BSA in supine position (e.g. due to organomegaly)

- Any underlying diseases affecting the peritoneal membrane transport function (such as
previous surgery with subsequent adhesions and fluid trapping, chronic bowl disease)

- Heart insufficiency

- Patients with catheter dysfunction, i.e. outflow problems (assessed by cycler alarms
during the last 2 weeks)



Age minimum: 5 Years
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Solute Removal

Primary Study Outcome: Sodium Clearance in Dialysis

Ultrafiltration

Intervention(s)

Other: Adapted double mini PET

Other: Standard double mini PET

Primary Outcome(s)

Dialytic sodium removal, i.e. the amount of sodium (mmol) per double mini PET (via ultrafiltration and diffusive sodium transport) [Time Frame: 2 x 150 min with one 1 hour inbetween each PET]

Secondary Outcome(s)

dialytic water and solute removal, i.e. ultrafiltrate per double mini PET (ml/gram intraperitoneal glucose exposure), phosphate removal per dmPET (mmol); Kt/V, clearance of creatinine (ml/min*1.73m²), intraperitoneal pressure (cm water) [Time Frame: 2 x 150 min with one 1 hour inbetween each PET]

Secondary ID(s)

S-545/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Great Ormond Street Hospital for Children NHS Foundation Trust

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Hôpital de Hautepierre