Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03222232
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2017-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Salvage in Intestinal Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D046248', 'term': 'Pyloric Stenosis, Hypertrophic'}, {'id': 'D000084063', 'term': 'Reinfection'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011707', 'term': 'Pyloric Stenosis'}, {'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 715}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-16', 'studyFirstSubmitDate': '2017-07-16', 'studyFirstSubmitQcDate': '2017-07-16', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new catheter-related bloodstream infections', 'timeFrame': '2002 to 2016', 'description': 'The occurrence of catheter-related bloodstream infection after either catheter salvaged (retained central venous catheter) or replaced central venous catheter (new central venous catheter)'}], 'secondaryOutcomes': [{'measure': 'recurrent catheter-related bloodstream infections', 'timeFrame': '2002 to 2016', 'description': 'A recurrent infection was defined as a CRBSI with identical microorganism and antibiogram occurring within 100 days of the previous CRBSI in a salvaged CVC.'}, {'measure': 'relapse catheter-related bloodstream infection', 'timeFrame': '2002 to 2016', 'description': 'A relapse infection was defined as recrudescence of the same causative microorganisms with identical antibiogram within 30 days of the previous CRBSI in a salvaged CVC.'}, {'measure': 'primary salvage rate', 'timeFrame': '2002 to 2016', 'description': 'The primary salvage rate was defined by the CVC status at hospital discharge. Because of the database setup and retrospective design of the study, all cases were included regardless of main reason to CVC removal (e.g. septic shock, severe sepsis, concomitant CVC problems and secondary or metastatic complications).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intestinal failure', 'catheter-related bloodstream infections', 'catheter salvage', 'recurrent infections', 'home parenteral support'], 'conditions': ['Intestinal Failure', 'Catheter-Related Bloodstream Infection (CRBSI) Nos']}, 'descriptionModule': {'briefSummary': 'This is an observational study evaluating a catheter salvage strategy in relation to catheter-related bloodstream infections in patients with chronic intestinal failure dependent on home parenteral support. The study is confined to the period 2002 to 2016.', 'detailedDescription': 'In chronic intestinal failure patients receiving home parenteral support (HPS), catheter-related bloodstream infections (CRBSIs) frequently results in replacement of their tunneled central venous catheters (CVCs) which may lead to future loss of central venous access.\n\nThis observational study investigates the consequences of a catheter-salvage-strategy related to CRBSIs according to different causative microorganisms, and short- and long-term risk of recurrence of the CRBSI. The study is based on the Copenhagen Intestinal failure database, which is a web-based database with retrospective data collection performed by reviews of medical charts from all adult intestinal failure patients discharged with home parenteral support from the Department of Medical Gastroenterology, Rigshospitalet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intestinal failure, characterised by a reduction in the guts capacity to absorb macronutrients and/or fluid and electrolytes below what is necessary to maintain health, and therefore parenteral support (nutrition and/or fluids and electrolytes) is required to sustain life. Patient initiated on Home parenteral support was entered into the Copenhagen Intestinal failure database, and thereby eligible in this cohorte study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic intestinal failure dependent on home parenteral support and enrolled in the Copenhagen Intestinal failure database\n\nExclusion Criteria:\n\n* Never discharged on home parenteral support'}, 'identificationModule': {'nctId': 'NCT03222232', 'briefTitle': 'Catheter Salvage in Intestinal Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Catheter-related Bloodstream Infections in Patients With Intestinal Failure Receiving Home Parenteral Support: Risks Related to a Catheter-salvage-strategy.', 'orgStudyIdInfo': {'id': 'CVC salvage study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic intestinal failure patients', 'description': 'Patients with chronic intestinal failure on home parenteral support and enrolled in the Copenhagen Intestinal failure database between January 1, 2002 and December 31, 2015.', 'interventionNames': ['Behavioral: catheter salvage']}], 'interventions': [{'name': 'catheter salvage', 'type': 'BEHAVIORAL', 'description': 'In each case of catheter-related bloodstream infection the management of the central venous catheter was registred to evaluate the future risk of new infections', 'armGroupLabels': ['chronic intestinal failure patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Siri Tribler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical gastroenterology, Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Palle Bekker Jeppesen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}