Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-07 @ 5:20 PM
Study NCT ID:
NCT02748733
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept of Adapted PD in Children (PC-AAPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010530', 'term': 'Peritoneal Dialysis'}], 'ancestors': [{'id': 'D006435', 'term': 'Renal Dialysis'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dialytic sodium removal, i.e. the amount of sodium (mmol) per double mini PET (via ultrafiltration and diffusive sodium transport)', 'timeFrame': '2 x 150 min with one 1 hour inbetween each PET', 'description': 'two double mini PET each comprising 150 min of dialysis'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': '2 x 150 min with one 1 hour inbetween each PET', 'description': 'two double mini PET each comprising 150 min of dialysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adapted APD', 'Dialytic Sodium Removal', 'Ultrafiltration', 'Clearance rate', 'Intraperitoneal pressure'], 'conditions': ['Primary Study Outcome: Sodium Clearance in Dialysis', 'Solute Removal', 'Ultrafiltration']}, 'referencesModule': {'references': [{'pmid': '26924063', 'type': 'RESULT', 'citation': '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': '23903692', 'type': 'RESULT', 'citation': 'Fischbach 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': '21454393', 'type': 'RESULT', 'citation': 'Fischbach 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PD patients 5-21 years of age\n* Stable PD\n* Last peritonitis \\> 4 weeks ago\n\nExclusion Criteria:\n\n* 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\n* Hypoalbuminemia (serum albumin \\< 25g/l)\n* Relevant changes in dialysis regime and diet the three days preceding the study\n* Hb \\< 9 mg/dl\n* Pregnancy\n* History of repeated hernia or PD fluid leakage\n* Intolerability of intraperitoneal pressure of up to 18 cm H2O at 1400ml/m²\n* BSA in supine position (e.g. due to organomegaly)\n* Any underlying diseases affecting the peritoneal membrane transport function (such as previous surgery with subsequent adhesions and fluid trapping, chronic bowl disease)\n* Heart insufficiency\n* Patients with catheter dysfunction, i.e. outflow problems (assessed by cycler alarms during the last 2 weeks)'}, 'identificationModule': {'nctId': 'NCT02748733', 'acronym': 'PC-AAPD', 'briefTitle': 'Proof of Concept of Adapted PD in Children (PC-AAPD)', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Randomized Cross-over Comparison of Double Mini PET With Standard vs. Adapted Dwell Volume and Dwell Time - Proof of Concept of Adapted PD', 'orgStudyIdInfo': {'id': 'S-545/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adapted double mini PET', 'description': '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):\n\nA 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.', 'interventionNames': ['Other: Adapted double mini PET']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard double mini PET', 'description': 'The Standard double mini PET consists of two identical cycles (fill volume 1 L/m², 75 min of dwell time)', 'interventionNames': ['Other: Standard double mini PET']}], 'interventions': [{'name': 'Adapted double mini PET', 'type': 'OTHER', 'otherNames': ['Peritoneal Equilibration Test (PET)', 'Peritoneal dialysis'], 'description': 'The modified double mini PET mimics the treatment of adapted PD and thus allows its validation', 'armGroupLabels': ['Adapted double mini PET']}, {'name': 'Standard double mini PET', 'type': 'OTHER', 'otherNames': ['Peritoneal Equilibration Test (PET)', 'Peritoneal dialysis'], 'description': 'The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison', 'armGroupLabels': ['Standard double mini PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Center for Pediatric and Adolescent Medicine', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Claus P Schmitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Pediatric and Adolescent Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, {'name': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Hôpital de Hautepierre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Claus Peter Schmitt', 'investigatorAffiliation': 'Heidelberg University'}}}}