Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02310035
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on the Course of Plasma Glutamine Levels During Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-12', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glutamine in serum', 'timeFrame': 'from admission up to 8 days', 'description': 'glutamine level at admission and during ICU stay daily'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glutamine Levels']}, 'referencesModule': {'references': [{'pmid': '26965168', 'type': 'DERIVED', 'citation': 'Buter H, Bakker AJ, Kingma WP, Koopmans M, Boerma EC. Plasma glutamine levels in patients after non-elective or elective ICU admission: an observational study. BMC Anesthesiol. 2016 Mar 10;16:15. doi: 10.1186/s12871-016-0180-7.'}]}, 'descriptionModule': {'briefSummary': 'Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission', 'detailedDescription': 'All patients who are admitted to the ICU after elective surgery and non-elective admissions. In both groups a total of 80 patients will be included.\n\n(In the trials we mentioned in the introduction 80, 174 and 66 patients were included. In the study performed by Oudemans-van Straaten a decent distribution between lower and higher levels of glutamine was achieved in 80 non-elective patients.) Exclusion criteria are patients younger then 18 years and patients who need total parenteral nutrition (TPN).\n\nThe patients will receive standard care during their treatment on the ICU. Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission. Hereafter plasma glutamine will be measured daily, a plasma sample will be taken from a standard evaluation blood sample at 6.00 am during admission on the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are admitted to the ICU after elective surgery and non-elective admissions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients admitted to the ICU\n\nExclusion Criteria:\n\n* younger then 18 years and patients who need total parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT02310035', 'briefTitle': 'Observational Study on the Course of Plasma Glutamine Levels During Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Observational Study on the Course of Plasma Glutamine Levels During Critial Illness', 'orgStudyIdInfo': {'id': 'nWMO48'}}, 'contactsLocationsModule': {'locations': [{'zip': '8934 AD', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medical Centre Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}], 'overallOfficials': [{'name': 'Matty Koopmans, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frisius Medisch Centrum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Matty Koopmans', 'investigatorAffiliation': 'Frisius Medisch Centrum'}}}}