Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-31 @ 6:54 PM
Study NCT ID:
NCT01636232
Status:
COMPLETED
Last Update Posted:
2016-06-06
First Post:
2012-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-03', 'studyFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients Outcome', 'timeFrame': '28 days', 'description': 'The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.'}, {'measure': 'Patients Outcome', 'timeFrame': '90 days', 'description': 'The survival time of patients more than 90 days is defined as survival. The survival time of patients less than 90 days is defined as death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'infection', 'disease severity', 'mortality', 'critically ill', 'sepsis'], 'conditions': ['Systemic Inflammatory Response Syndrome', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '23876904', 'type': 'DERIVED', 'citation': 'Su LX, Jiang ZX, Cao LC, Xiao K, Song JP, Li H, Zhang X, Yan P, Feng D, Liu CT, Li X, Xie LX. Significance of low serum vitamin D for infection risk, disease severity and mortality in critically ill patients. Chin Med J (Engl). 2013 Jul;126(14):2725-30.'}]}, 'descriptionModule': {'briefSummary': "The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in critical condition. Especially, vitamin D level below normal prolongs hospital stay and increases incidence of adverse prognosis and pushing up mortality of a number of diseases. However, it is remain unclear the relationship between vitamin D levels and critically ill, especially infection or sepsis. In this study, the investigators evaluate the significance of vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's relevance to sepsis, as well as its value in severity and prognosis assessment, high-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of the total 25(OH)D in serum of critically ill patients. The investigators speculate that measurement of vitamin D could be taken as an indicator for diagnosis and assessment in critically ill patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the subjects were selected from among inpatients who were hospitalized between October-December, 2011 in the Surgical ICU, Respiratory ICU, and Emergency ICU, Chinese PLA General Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female aged 18 years old and over;\n* Entered ICU;\n* Fulfilled at least two criteria of systemic inflammatory response syndrome\n\n * core temperature higher than 38 °C or lower than 36 °C\n * respiratory rate above 20/min, or PCO2 below 32 mmHg\n * pulse rate above 90/min, and\n * white blood cell count greater than 12,000/μl or lower than \\< 4,000/μl or less than 10% of bands.\n\nExclusion Criteria:\n\n* patients or their relatives refused'}, 'identificationModule': {'nctId': 'NCT01636232', 'briefTitle': 'Vitamin D and Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Vitamin D Levels and Risk of Infection, Assessment for Disease Severity, and Predictor of Mortality in the Chinese Intensive Care Units: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CPLAGH-2012026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU sepsis group', 'description': 'The ICU sepsis group consisting of 105 critically-ill cases diagnosed with sepsis upon admission and sampled within the first 24h of their ICU stay.'}, {'label': 'ICU control group', 'description': 'the ICU control group including 51 critically-ill cases in whom sepsis was clinically excluded and from whom samples were taken upon admission.'}, {'label': 'healthy control group', 'description': 'the healthy control group composed of 50 healthy control outpatients. For the healthy control outpatients, possibilities of acute or past chronic diseases were excluded. Moreover, we made sure that the healthy control subjects had not been hospitalized or taken vitamin-based substitutive drugs in the last 12 months, and proved normal in physical checkups and lab examinations.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Lixin Xie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department Of Respiratory Diseases, Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Longxiang Su', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}