Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05967858
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Refeeding Syndrome in Consecutively Admitted Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055677', 'term': 'Refeeding Syndrome'}, {'id': 'D013217', 'term': 'Starvation'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refeeding syndrome', 'timeFrame': '1 week after start of nutrition', 'description': 'No. patients with decrease in plasma phosphate + clinical symptoms'}], 'secondaryOutcomes': [{'measure': 'Refeeding phenomenon', 'timeFrame': '1 week after start of nutrition', 'description': 'No. patients with decrease in plasma phosphate after start of nutrition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refeeding Syndrome', 'Starvation', 'Phosphate Deficiency']}, 'descriptionModule': {'briefSummary': 'The incidence and main risk-factors analyzed in consecutive in-patients in the departments og gastroenterology and ear-nose and throat diseases (cancer in radiation therapy)', 'detailedDescription': 'Patients with either parenteral- or tube feeding enter the study to assure sufficient nutrition.\n\nDuring hospitalization patients were monitored with daily blood samples and clinical evaluation of symptoms in addition to the coverage of energy and protein in percent of estimated needs.\n\nRefeeding phenomenon was defined as a decrease in plasma phosphate after the initiation of nutrition.\n\nRefeeding syndrome as refeeding phenomenon and one or more relevant symptoms in addition (hypotension, cardiac arrhythmia, edema, confusion)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'No other than willingness to participate and consecutively admitted, as well as planned sufficient nutrition', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned tube- or parenteral nutrition (complete or supplementary)\n* \\> 18 years\n* written consent\n\nExclusion Criteria:\n\n* Renal insufficiency (p-creatinine \\>200 micromol/l)\n* Lack of ability to communicate (registration of nutritional intake etc)'}, 'identificationModule': {'nctId': 'NCT05967858', 'briefTitle': 'Incidence of Refeeding Syndrome in Consecutively Admitted Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Refeeding Syndrome - Incidence and Risk Factors: An Observational Study on Patients With G-I Disease and Head-neck Cancer', 'orgStudyIdInfo': {'id': 'norge refeed'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gastroenterological', 'description': 'Consecutive admissions - n= 43 - 34 operated (79%) - 10 patients acutely admitted Diseases in Esophagus (8), gastric cavity (8), pancreas (7), colon/rectum (8), bile (4), small intestine (3), IBD (5) No interventions in the treatments, just observation', 'interventionNames': ['Other: observation']}, {'label': 'head and neck cancer', 'description': 'Consecutive admissions - n=8 - 7 radiation therapy - 1 operated Locations: 2 Larynx, 1 oro-pharynx, 4 tonsillar, 1 tung No interventions in the treatments, just observation', 'interventionNames': ['Other: observation']}], 'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['gastroenterological', 'head and neck cancer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'jens R Andersen, MD, MPA', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}