Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 8:01 AM
Study NCT ID:
NCT03359369
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the level of serum cholesterol and triglyceride', 'timeFrame': 'on days 0, 1, 3, and 7, 10 and 14 days', 'description': 'change in the level of serum cholesterol and triglyceride'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Patients', 'Nonseptic Patients']}, 'descriptionModule': {'briefSummary': 'The primary outcome of this study is to evaluate the difference between the level of serum cholesterol and triglyceride in septic and non septic patients in the ICU. .\n\nThe secondary outcome will be to find correlation between the level of serum cholesterol and triglyceride and both Acute physiology And Chronic Health Evaluation Score (APACHE) II(19) and quick Sequential Organ Failure Assessment (qSOFA) score (20) and their relation to mortality.', 'detailedDescription': 'Type and Site of The study:\n\nThis study will be be done at Beni-Suef university hospital SICU after approval of the local ethics and research committee and anesthesia department of Beni-Suef University.\n\nDATE AND PERIOD OF THE STUDY:\n\nThe study will be done between June 2017 and June 2018\n\nStudy population:\n\nThe study population will include the patients (age range between 20 and 70)of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni Suef University hospital.\n\nSample size estimation:\n\nSample technique:\n\nThe patients will be randomly assigned into two groups, septic patients (groups) according to established consensus definitions (21) or non septic patients (NS) as post surgical and trauma patients.\n\nThe following data will be recorded for each patient: age, sex,weight, cause of ICU admission, administration of vasoactive drugs, length of ICU stay, 28-day mortality, administration of vasoactive drugs, days on mechanical ventilation, Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, quick Sequential Organ Failure Assessment (qSOFA) scores will be recorded.\n\nThe following laboratory data will be measured:\n\ncholesterol, triglyceride on days 0 (ICU admission), 1, 3, and 7, 10 and 14.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include the patients (age range between 20 and 70) of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni-Suef University hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study population will include the patients (age range between 20 and 70) of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni-Suef University hospital\n\nExclusion Criteria:\n\n* Age less than 20\n* Pregnancy\n* ICU readmission\n* Dyslipidemia\n* Patients with liver disease e.g.hepatitis B,hepatitis C , liver cirrhosis, and hepatocellular carcinoma)\n* Concomitant of use immunosuppressive therapy\n* Using statin or steroid (≥15mg/day) within the previous 7 days\n* Patients who had been treated with corticosteroid therapy for septic shock prior to admission to ICU\n* Patients sedated by propofol'}, 'identificationModule': {'nctId': 'NCT03359369', 'briefTitle': 'Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients: Randomized Double Blinded Study', 'orgStudyIdInfo': {'id': 'doaa rashwan'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic Patients', 'interventionNames': ['Diagnostic Test: level of serum cholesterol and triglyceride']}, {'label': 'Non Septic Patients', 'interventionNames': ['Diagnostic Test: level of serum cholesterol and triglyceride']}], 'interventions': [{'name': 'level of serum cholesterol and triglyceride', 'type': 'DIAGNOSTIC_TEST', 'description': 'other', 'armGroupLabels': ['Non Septic Patients', 'Septic Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11391', 'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Faculty Of Medicine, Beni-Suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'doaa rashwan', 'investigatorAffiliation': 'Beni-Suef University'}}}}