Proof of Concept of Adapted PD in Children (PC-AAPD)
PC-AAPD
Randomized Cross-over Comparison of Double Mini PET With Standard vs. Adapted Dwell Volume and Dwell Time - Proof of Concept of Adapted PD
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMay 8, 2018
May 1, 2018
1.6 years
April 13, 2016
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dialytic sodium removal, i.e. the amount of sodium (mmol) per double mini PET (via ultrafiltration and diffusive sodium transport)
two double mini PET each comprising 150 min of dialysis
2 x 150 min with one 1 hour inbetween each PET
Secondary Outcomes (1)
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)
2 x 150 min with one 1 hour inbetween each PET
Study Arms (2)
Adapted double mini PET
ACTIVE COMPARATORPET = Peritoneal Equilibration Test, a test routinely performed to measure peritoneal transport rates of solutes and water in peritoneal dialysis patients. To this end the routinely administered dialysis fluid is infused into the peritoneal cavity. The test will be modified (adapted): A short, small cycle (0.6 mL/m² BSA, 30 min) followed by a long, large cycle (1.4 mL/m², 120 min) will be performed in each patient and compared to a standard double mini PET.
Standard double mini PET
PLACEBO COMPARATORThe Standard double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min of dwell time)
Interventions
The modified double mini PET mimics the treatment of adapted PD and thus allows its validation
The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison
Eligibility Criteria
You may qualify if:
- PD patients 5-21 years of age
- Stable PD
- Last peritonitis \> 4 weeks ago
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Pediatric and Adolescent Medicine
Heidelberg, Baden-Wurttemberg, 69120, Germany
Related Publications (3)
Fischbach M, Schmitt CP, Shroff R, Zaloszyc A, Warady BA. Increasing sodium removal on peritoneal dialysis: applying dialysis mechanics to the peritoneal dialysis prescription. Kidney Int. 2016 Apr;89(4):761-6. doi: 10.1016/j.kint.2015.12.032. Epub 2016 Jan 21.
PMID: 26924063RESULTFischbach M, Zaloszyc A, Schaefer B, Schmitt CP. Optimizing peritoneal dialysis prescription for volume control: the importance of varying dwell time and dwell volume. Pediatr Nephrol. 2014 Aug;29(8):1321-7. doi: 10.1007/s00467-013-2573-x. Epub 2013 Aug 2.
PMID: 23903692RESULTFischbach M, Issad B, Dubois V, Taamma R. The beneficial influence on the effectiveness of automated peritoneal dialysis of varying the dwell time (short/long) and fill volume (small/large): a randomized controlled trial. Perit Dial Int. 2011 Jul-Aug;31(4):450-8. doi: 10.3747/pdi.2010.00146. Epub 2011 Mar 31.
PMID: 21454393RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus P Schmitt, MD
Center for Pediatric and Adolescent Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 22, 2016
Study Start
April 1, 2016
Primary Completion
October 31, 2017
Study Completion
January 1, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share