Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05813535
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
8.4% Sodium Bicarbonate Locks in Intestinal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090124', 'term': 'Intestinal Failure'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-04-02', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of catheter related bloodstream infections', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of infections per 1000 catheter days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Failure', 'CRBSI - Catheter Related Bloodstream Infection']}, 'descriptionModule': {'briefSummary': 'We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.', 'detailedDescription': 'Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration\n* Subject is less than 18 years of age at the time of study entry\n* Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)'}, 'identificationModule': {'nctId': 'NCT05813535', 'briefTitle': '8.4% Sodium Bicarbonate Locks in Intestinal Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Sodium Bicarb Locks in Intestinal Failure', 'orgStudyIdInfo': {'id': '202205087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Baseline', 'description': 'Patient on heparin locks when off venous nutrition', 'interventionNames': ['Drug: Sodium bicarb lock']}], 'interventions': [{'name': 'Sodium bicarb lock', 'type': 'DRUG', 'description': '8.4% sodium bicarb locks when off venous nutrition', 'armGroupLabels': ['Baseline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Riad Rahhal, MD', 'role': 'CONTACT', 'email': 'riad-rahhal@uiowa.edu'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'centralContacts': [{'name': 'Riad Rahhal, MD', 'role': 'CONTACT', 'email': 'riad-rahhal@uiowa.edu', 'phone': '+1 319 356 2950'}, {'name': 'Kathy Bell', 'role': 'CONTACT', 'email': 'kathy-bell@uiowa.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riad Rahhal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Riad Rahhal', 'investigatorAffiliation': 'University of Iowa'}}}}