Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01977716
Status:
UNKNOWN
Last Update Posted:
2013-11-25
First Post:
2013-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peritonitis and Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-06-25', 'releaseDate': '2019-03-15'}, {'resetDate': '2023-06-09', 'releaseDate': '2022-07-21'}], 'estimatedResultsFirstSubmitDate': '2019-03-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Death', 'timeFrame': '25 months'}], 'primaryOutcomes': [{'measure': 'Loss of residual renal function', 'timeFrame': '25 months'}, {'measure': 'Technique (peritoneal dialysis) failure', 'timeFrame': '25 months', 'description': 'Shift to hemodialysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peritonitis', 'loss of residual renal function', 'technique survival'], 'conditions': ['Loss of Residual Renal Function', 'Technique Failure in Peritoneal Dialysis']}, 'descriptionModule': {'briefSummary': 'The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk factors for loss of residual renal function, technique failure and mortality in chronic kidney disease patients.\n\nSecondary objectives are: To know the current rate of peritonitis in peritoneal dialysis population and to understand the bacteriological profile of peritonitis.\n\nTo know the rate and risk factors other than peritonitis involved in the loss of residual renal function.\n\nTo analyze the utility of alternative diagnostic tests, such as reagent strips, for early detection of peritonitis when traditional tests are not available.\n\nTo analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative measurements of peritoneal clearance and residual renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients starting PD as the first dialysis treatment will be considered. Recruitment will take place over a six-months period in hospitals belonging to the Instituto Mexicano de Seguro Social. Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease. Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease.\n\n\\-\n\nExclusion Criteria:Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01977716', 'briefTitle': 'Peritonitis and Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'The Role of Peritonitis in the Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'R-2013-785-069'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Incident peritoneal dialysis patients', 'description': 'Patients with chronic kidney disease incident to peritoneal dialysis treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06722', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'contacts': [{'name': 'Ramon Paniagua, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Catarina Munguia-Miranda, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria de Jesus Ventura-Garcia, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Ramon Paniagua, MD, PhD', 'role': 'CONTACT', 'email': 'jrpaniaguas@gmail.com', 'phone': '+52-55-56276900', 'phoneExt': '21371'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-03-15', 'type': 'RELEASE'}, {'date': '2019-06-25', 'type': 'RESET'}, {'date': '2022-07-21', 'type': 'RELEASE'}, {'date': '2023-06-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Coordinación de Investigación en Salud, Mexico'}}}}