Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-07 @ 5:17 PM
Study NCT ID:
NCT04102527
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether there is a relationship between transit disorders and the rate of digestive germ peritonitis in patients with Terminal Chronic Kidney disease on Peritoneal Dialysis', 'timeFrame': '4 years', 'description': 'The investigators will count the number of peritonitis associated with transit disorders in patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis'}], 'secondaryOutcomes': [{'measure': 'To determine whether there are variations in the relationship between transit disorders and the rate of peritonitis depending on the therapeutic management of these transit disorders.', 'timeFrame': '4 years', 'description': 'To assess the existence of an episode of peritonitis from all causes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Dialysis Complication', 'Constipation']}, 'descriptionModule': {'briefSummary': 'Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.\n\nIn this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.', 'detailedDescription': 'Patients included in this trial will be monitored as part of the usual management of their pathology, a Terminal Chronic Kidney Disease treated by the Peritoneal Dialysis technique.\n\nDuring this treatment, patients will be follow every 2 months in consultation in the Metabolic Diseases Department of the Hospital of Vichy.\n\nThese consultations include:\n\n* Pre-selection consultation/Inclusion (visit to J0 -3 months)\n* Half-yearly review (visit J0, visit at 12 months and visit at 24 months)\n* Simple consultation (visits to 2, 4, 8, 10, 14, 16, 20, 22 months)\n* Annual review (visits at 6 and 18 months)\n\nIn this prospective trial, there is no intervention on the patient; They will only have to complete questionnaires on their intestinal transit (Charlson Scale, Katz Scale, Neurological Functional Score, Intestinal Function Index, Severity Score for constipation, Bristol Scale, Constipation Assessment Scale, Constipation Risk Assessment Scale). No minimal risk and constraint is identified, excluding our trial from the category of interventional research. The category 3 (non-interventional trial) of the jardé classification is therefore accepted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinically stable patients who have been in Peritoneal Dialysis for at least three months will be pre-selected three months before the start of the study and included via the Metabolic diseases Center of the Hospital.\n\nThis protocol will be offered to adult patients suffering from Terminal Chronic Kidney disease undergoing Peritoneal Dialysis.\n\nThe investigator will inform the details of the protocol and answer all questions from patients. It will be given sufficient time to reflect for the signing of the information and non-opposition form. Volunteers will be included after signing this document.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with TerminalChronic Kidney disease undergoing Peritoneal Dialysis for at least three months in stable condition,\n* Patients who are able to complete the study questionnaires every 2 months,\n* Cooperation and understanding sufficient to comply with the requirements of the study,\n* Ability to understand the French language for an informed understanding of the information and non-opposition forms,\n* Affiliation with the French Social Security scheme.\n\nExclusion Criteria:\n\n* Patients whose peritoneal dialysis catheter is considered non-functional at J0,\n* Patients with a medical and/or surgical history considered by the investigator or his representative to be not compatible with the trial,\n* Patients with unstabilized progressive pathology at the time of inclusion at J0,\n* Patients who are mentally incapacitated to answer questionnaires,\n* Women of childbearing age who do not use an effective contraceptive method, pregnant or lactating women.\n* Patients with legal protection measures (curatorship, guardianship, etc.).'}, 'identificationModule': {'nctId': 'NCT04102527', 'acronym': 'TransDiPe', 'briefTitle': 'Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Vichy'}, 'officialTitle': 'Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal', 'orgStudyIdInfo': {'id': 'CHV 2018-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis for at least three months in stable condition', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Patients have to complete the study questionnaires every 2 months :\n\n* Digestive Functional Score of Neurological Patients\n* Bowel Function Index\n* Severity score for constipation\n* Bristol Scale\n* Constipation assessment scale\n* Estimate scale of risk of constipation', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03200', 'city': 'Vichy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine ROUX', 'role': 'CONTACT', 'email': 'delphine.roux@ch-vichy.fr', 'phone': '0033470971314'}, {'name': 'Didier AGUILERA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julie ALBARET', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital center', 'geoPoint': {'lat': 46.12709, 'lon': 3.42577}}], 'centralContacts': [{'name': 'Delphine ROUX', 'role': 'CONTACT', 'email': 'delphine.roux@ch-vichy.fr', 'phone': '0033470971314'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations.\n\nThe protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book.\n\nSource data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators.\n\nThe data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry.\n\nDuring or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Vichy', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}