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

May 2, 2018 updated by: Claus Peter Schmitt, Heidelberg University

Randomized Cross-over Comparison of Double Mini PET With Standard vs. Adapted Dwell Volume and Dwell Time - Proof of Concept of Adapted PD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Present peritoneal dialysis treatment is hampered by the limited efficacy of currently applied regimen, mainly consisting of a series of standard dwells with the same amount of dialysate and dwell time. New cycler machines available for routine therapy now allow modification of time and volume of each dwell and thus to individually adapt PD regime. In fact a recent multi-center trial in adult patients suggests that a PD regimen consisting of a sequence of short small dwells followed by large and long lasting dwells in total applying the same amount of dialysate during the same total treatment time substantially improves fluid and toxin removal. Underlying beneficial mechanisms are highly debated. Prior to adaptation of such PD treatment patterns to children on automated PD in the routine clinical setting, the tolerability and biochemical effects need to be demonstrated.

To this end, the Peritoneal Equilibration Test (PET), which is routinely performed in children during a day hospital treatment to analyse peritoneal transport function, will be modified. 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 in a total of 15 stable pediatric PD patients treated in four different European pediatric dialysis centres. The conventional double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min), the adapted one of a short, small cycle (0.6 mL/m² BSA, 30 min) followed by a long, large cycle (1.4 mL/m², 120 min). A total of 22 ml of blood will be drawn via a peripheral i.v. line, intraperitoneal pressure, in clinical routine controlled once during a PET, will be measured with each dwell.

The study analyses the time and volume dependent PD transport mechanisms. Patients included may benefit from the detailed analysis of peritoneal membrane function, allowing for optimisation of the individual PD prescription.

Study Type

Interventional

Enrollment (Actual)

15

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 Locations

  • Germany
    • BW
      • Heidelberg, BW, Germany, 69120
        • Center for Pediatric and Adolescent Medicine

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

5 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Adapted double mini PET

PET = 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.
Other: Adapted double mini PET
The modified double mini PET mimics the treatment of adapted PD and thus allows its validation
Other Names:
  • Peritoneal Equilibration Test (PET)
  • Peritoneal dialysis
PLACEBO_COMPARATOR: Standard double mini PET
The Standard double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min of dwell time)
Other: Standard double mini PET
The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison
Other Names:
  • Peritoneal Equilibration Test (PET)
  • Peritoneal dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two double mini PET each comprising 150 min of dialysis
2 x 150 min with one 1 hour inbetween each PET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two double mini PET each comprising 150 min of dialysis
2 x 150 min with one 1 hour inbetween each PET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Great Ormond Street Hospital for Children NHS Foundation Trust
Hôpital de Hautepierre

Investigators

  • Principal Investigator: Claus P Schmitt, MD, Center for Pediatric and Adolescent Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

October 31, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (ESTIMATE)

April 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-545/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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