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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Administration of pH-Neutral Peritoneal Dialysis Solutions Containing Lactate or Bicarbonate in Children

NCT01632046

Chronic Renal Failure Peritoneal Membrane Disorder

COMPLETED PHASE4

A Study Comparing the Impact of Mini-exchange-room and Usual Care on Physical Activity and Quality of Life in Peritoneal Dialysis Patients

NCT01982344

Physical Activity Quality of Life

COMPLETED NA

Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients

NCT06443021

Renal Failure Chronic Kidney Diseases

WITHDRAWN NA

Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

NCT02044614

Functionally Anuric Hemodialysis/Peritoneal Dialysis

TERMINATED NA

Transfer and Ultrafiltration In Peritoneal Dialysis

NCT02474719

End-stage Renal Disease

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Study Outcome: Sodium Clearance in Dialysis Solute Removal Ultrafiltration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Adapted double mini PET

Intervention Type OTHER

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

Standard double mini PET

The Standard double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min of dwell time)

Group Type PLACEBO_COMPARATOR

Standard double mini PET

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adapted double mini PET

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

Intervention Type OTHER

Standard double mini PET

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Peritoneal Equilibration Test (PET) Peritoneal dialysis Peritoneal Equilibration Test (PET) Peritoneal dialysis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No