Primary Study Outcome: Sodium Clearance in DialysisPC-AAPDNCT02748733
Proof of Concept of Adapted PD in Children (PC-AAPD)
A study testing Adapted double mini PET and Standard double mini PET in people with Primary Study Outcome: Sodium Clearance in Dialysis and Solute Removal, run by Heidelberg University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Primary Study Outcome: Sodium Clearance in Dialysis, Solute Removal, Ultrafiltration
- What is being tested?
- Adapted double mini PET and Standard double mini PET
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PD patients 5-21 years of age
- Stable PD
- Last peritonitis > 4 weeks ago
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Pediatric and Adolescent Medicine
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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.
Read the 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.
- Being tested
- Adapted double mini PET, Standard double mini PET
- Keywords
- Adapted APD, Dialytic Sodium Removal, Ultrafiltration, Clearance rate, Intraperitoneal pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted double mini PETOther
Also called Peritoneal Equilibration Test (PET), Peritoneal dialysis
The modified double mini PET mimics the treatment of adapted PD and thus allows its validation
Standard double mini PETOther
Also called Peritoneal Equilibration Test (PET), Peritoneal dialysis
The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison
| Study group | Role | What they receive |
|---|---|---|
| Adapted double mini PET | Active comparator | 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. Receives: Other: Adapted double mini PET |
| Standard double mini PET | Placebo comparator | The Standard double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min of dwell time) Receives: Other: Standard double mini PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
two double mini PET each comprising 150 min of dialysis
Measured: 2 x 150 min with one 1 hour inbetween each PET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion31 Oct 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Study Outcome: Sodium Clearance in DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Great Ormond Street Hospital for Children NHS Foundation Trust, Hôpital de Hautepierre
- Responsible party
- Principal investigator, Claus Peter Schmitt, Heidelberg University
- Investigators
- Claus P Schmitt, MD, Principal investigator, Center for Pediatric and Adolescent Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748733
- Sponsor's protocol ID
- S-545/2015
- Acronym
- PC-AAPD
- Status last verified
- May 2018
- First submitted
- 13 Apr 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26924063Fischbach 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.
PubMed 23903692Fischbach 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.
PubMed 21454393
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Comparison of Double Mini PET With Standard vs. Adapted Dwell Volume and Dwell Time - Proof of Concept of Adapted PD
- ClinicalTrials.gov ID
- NCT02748733
- Acronym / sponsor ID
- PC-AAPD / S-545/2015
- Keywords
- Adapted APD, Dialytic Sodium Removal, Ultrafiltration, Clearance rate, Intraperitoneal pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Great Ormond Street Hospital for Children NHS Foundation Trust, Hôpital de Hautepierre
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted double mini PET | Active comparator | Other: Adapted double mini PETPET = 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 comparator | Other: Standard double mini PETThe Standard double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min of dwell time) |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- PD patients 5-21 years of age
- Stable PD
- Last peritonitis > 4 weeks ago
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted double mini PETAlso: Peritoneal Equilibration Test (PET), Peritoneal dialysisThe modified double mini PET mimics the treatment of adapted PD and thus allows its validation | Other | Adapted double mini PET |
| Standard double mini PETAlso: Peritoneal Equilibration Test (PET), Peritoneal dialysisThe standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison | Other | Standard double mini PET |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Results publication: PubMed 26924063Fischbach 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.
- Results publication: PubMed 23903692Fischbach 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.
- Results publication: PubMed 21454393Fischbach 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus P Schmitt, MD principal investigator
Center for Pediatric and Adolescent Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted double mini PET and Standard double mini PET in people with Primary Study Outcome: Sodium Clearance in Dialysis and Solute Removal, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748733, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.