Nctid:
NCT06224881
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012772", "term"=>"Shock, Septic"}, {"id"=>"D012614", "term"=>"Scurvy"}, {"id"=>"D001206", "term"=>"Ascorbic Acid Deficiency"}, {"id"=>"D012769", "term"=>"Shock"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D018805", "term"=>"Sepsis"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D018746", "term"=>"Systemic Inflammatory Response Syndrome"}, {"id"=>"D007249", "term"=>"Inflammation"}, {"id"=>"D001361", "term"=>"Avitaminosis"}, {"id"=>"D003677", "term"=>"Deficiency Diseases"}, {"id"=>"D044342", "term"=>"Malnutrition"}, {"id"=>"D009748", "term"=>"Nutrition Disorders"}, {"id"=>"D020141", "term"=>"Hemostatic Disorders"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D006474", "term"=>"Hemorrhagic Disorders"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}], "browseLeaves"=>[{"id"=>"M15577", "name"=>"Shock", "asFound"=>"Shock", "relevance"=>"HIGH"}, {"id"=>"M15580", "name"=>"Shock, Septic", "asFound"=>"Septic Shock", "relevance"=>"HIGH"}, {"id"=>"M4514", "name"=>"Ascorbic Acid Deficiency", "asFound"=>"Vitamin C Deficiency", "relevance"=>"HIGH"}, {"id"=>"M15430", "name"=>"Scurvy", "asFound"=>"Vitamin C Deficiency", "relevance"=>"HIGH"}, {"id"=>"M20864", "name"=>"Sepsis", "relevance"=>"LOW"}, {"id"=>"M16869", "name"=>"Toxemia", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M20818", "name"=>"Systemic Inflammatory Response Syndrome", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M4660", "name"=>"Avitaminosis", "relevance"=>"LOW"}, {"id"=>"M6879", "name"=>"Deficiency Diseases", "relevance"=>"LOW"}, {"id"=>"M25306", "name"=>"Malnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M21977", "name"=>"Hemostatic Disorders", "relevance"=>"LOW"}, {"id"=>"M5059", "name"=>"Blood Coagulation Disorders", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M9560", "name"=>"Hemorrhagic Disorders", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"T5155", "name"=>"Scurvy", "asFound"=>"Vitamin C Deficiency", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D001205", "term"=>"Ascorbic Acid"}], "ancestors"=>[{"id"=>"D000975", "term"=>"Antioxidants"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}], "browseLeaves"=>[{"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M4513", "name"=>"Ascorbic Acid", "asFound"=>"Strain", "relevance"=>"HIGH"}, {"id"=>"M4292", "name"=>"Antioxidants", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T477", "name"=>"Vitamin C", "asFound"=>"Strain", "relevance"=>"HIGH"}, {"id"=>"T437", "name"=>"Ascorbic Acid", "asFound"=>"Strain", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>150}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-12-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-01-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2023-12-28", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-01-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"C-reactive protein", "timeFrame"=>"Evaluated on a daily basis for 4 days", "description"=>"C-reactive protein level III- Vasopressor (noradrenaline) dose and duration"}, {"measure"=>"Mean arterial blood pressure", "timeFrame"=>"Evaluated on a daily basis for 4 days", "description"=>"Mean arterial blood pressure (MAP)."}], "secondaryOutcomes"=>[{"measure"=>"ICU Length of stay . II- 7 day mortality rate. III- 28 days mortality", "timeFrame"=>"28 days", "description"=>"ICU Length of stay II- 7 day mortality rate. III- 28 days mortality"}, {"measure"=>"ICU mortality", "timeFrame"=>"28 days", "description"=>"ICU mortality"}]}, "oversightModule"=>{"isUsExport"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Septic Shock"]}, "descriptionModule"=>{"briefSummary"=>"Objectives: investigators aim to study the effect of addition of vitamin C as a part of treatment in septic shock patients on: Hemodynamics, Inflammation status and ICU outcome.\n\nSubjects and methods: A prospective interventional randomized cohort study, was conducted on 150 consecutive patients who were admitted to the ICU with septic shock based on SIRS, SOFA and APACHE II. Treatment group (n=75) had given ascorbic acid (Vitamin C) parenterally 6gm daily and control group (n=75). Measuring the level of Vitamin C in all study population (normal range 50-70 μM/L) before and after period of 4 days.", "detailedDescription"=>"AIM OF THE WORK investigators aim to study the effect of addition of vitamin C in septic shock patients on:\n\n* Mean arterial pressure\n* C-reactive protein as an inflammatory marker\n* Vasopressors ( norepinephrine) dose and duration.\n* ICU outcome ( ICU stay, 7 and 28 days mortality)\n\nSUBJECTS AND METHODS\n\nStudy type A prospective interventional randomized cohort study carried out at Critical Care Department, Cairo University Hospitals with 25 ICU beds for medical and surgical patients, in the period between December 2021 to January 2023.\n\nAn informed consent from 1st degree relatives was taken and confidentiality of information was assured.\n\nPermission from the faculty of medicine ethical committee was obtained. Ethical committee approval number: MS-362-2019\n\nStudy design of the study population The patients' demographic data (including age, sex, baseline diseases, and causes of ICU admission) were extracted from their medical charts, and the patients' clinical characteristics (such as vital signs and hemodynamic parameters) were monitored as daily interval.\n\nLaboratory data such as serum electrolyte concentrations, serum creatinine levels were extracted from the patients' medical charts.\n\nVit C level was measured for all patients (normal range 50-70 μM/L).\n\nThe patients' Acute Physiology and Chronic Health Evaluation II (APACHE II) and sequential organ failure assessment (SOFA) scores were calculated at the time of admission.\n\nPatients were randomly divided into 2 groups into:\n\nA) Treatment group (n=75) B) Control group (n=75) Ascorbic acid (Vitamin C) was given parenterally for the treatment group (2 gm every 8hrs) for 4 days.\n\nRemeasuring the level of Vitamin C in all study population after 4 days.\n\n• Measurement and administration of Vitamin C Vitamin C (Ascorbic Acid) parenteral formula Manufacturer: Arco Life sciences ( Http://www.arcolifesciences.co.in/ ) Ampules: each ampule contains 500 mg of ascorbic acid (5 ml each 1 ml contains 100mg) The dose and duration of intervention were selected based on the literature review.\n\nEach dose of ascorbic acid was diluted in 50 ml of dextrose 5% solution and was administered as intravenous infusion over 30 minutes.\n\nDuring the study period, patients were followed for any ascorbic acid-related adverse effects including nausea, vomiting, abdominal pain, hematuria, flushing, and significant arterial blood pressure change.\n\nMeasurement Kits This kit is an Enzyme-Linked Immunosorbent Assay (ELISA). The plate has been pre-coated with human Vitamin C antibody (VC). VC present in the sample is added and binds to antibodies coated on the wells. Substrate solution is then added and color develops in proportion to the amount of human VC and absorbance is measured at 450 nm.\n\n* Manufacturer Bioassay Technology Labs\n* Serial number: E1538Hu\n* Standard Curve Range: 200 Mg/ml - 300 Mg/ml\n* Sensitivity: 0.52 Mg/ml\n* Size: 96 wells\n* Storage: Store the reagents at 2-8°C. For over 6-month storage refer to the expiration date keep it at -20°C. Avoid repeated thaw cycles. If individual reagents are opened it is recommended that the kit be used within 1 month.\n* Specimen Collection Serum Allow serum to clot for 10-20 minutes at room temperature. Centrifuge at 2000-3000 RPM for 20 minutes Plasma Collect plasma using EDTA or heparin as an anticoagulant. Centrifuge samples for 15 minutes at 2000-3000 RPM at 2 - 8°C within 30 minutes of collection.\n* Calculation of results :\n\nPlasma vitamin C level were measured by Vitamin C ELISA Kits by microgram /milliliter (μg/ml) and calculated to micromole/ L (μM/L) in factor of 5.6679 and results were given accordingly\n\n• Normal range of Vitamin C in plasma : Multiple ranges are given in the level of vitamin C but recent studies consider range of (50-70μ M/L) is the reference in patients with sepsis and septic shock .\n\nStatistical analysis Analysis of data was done using Statistical Program for Social Science version 20 (SPSS Inc., Chicago, IL, USA). Quantitative variables were described in the form of mean and standard deviation. Qualitative variables were described as number and percent. In order to compare parametric quantitative variables between two groups, Student t test was performed. Qualitative variables were compared using chi-square (X2) test or Fisher's exact test when frequencies were below five. Pearson correlation coefficients were used to assess the association between two normally distributed variables. When a variable was not normally distributed, A P value \\< 0.05 is considered significant The used tests were Chi-square test For categorical variables, to compare between different groups, Fisher's Exact or Monte Carlo correction for chi-square when more than 20% of the cells have expected count less than 5,Student t-test For normally distributed quantitative variables, to compare between two studied groups, ANOVA with repeated measures for normally distributed quantitative variables, to compare between more than two periods or stages, and Post Hoc test (Bonferroni adjusted) for pairwise comparisons, Pearson coefficient To correlate between two normally distributed quantitative variables, Mann Whitney test For abnormally distributed quantitative variables, to compare between two studied groups, Friedman test For abnormally distributed quantitative variables, to compare between more than two periods or stages and Post Hoc Test (Dunn's) for pairwise comparisons and Q: Cochran's test For non-parametric test for binary response variable and Post Hoc Test (Dunn's) for pairwise comparisons."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Septic shock (defined by sepsis induced hypotension i.e. MAP \\< 65 mmHg, tissue hypo-perfusion, vasopressors\n\nExclusion Criteria:\n\n* Age below 18 years old"}, "identificationModule"=>{"nctId"=>"NCT06224881", "briefTitle"=>"Vitamin C Deficiency in Septic Shock", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Treating Vitamin C Deficiency in Septic Shock: Would it Help?", "orgStudyIdInfo"=>{"id"=>"MS-362-2019"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Vitamin C group", "description"=>"Ascorbic acid (Vitamin C) was given parenterally (2 gm every 8hrs) for 4 days.", "interventionNames"=>["Drug: Ascorbic acid"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control group", "description"=>"No vit C given", "interventionNames"=>["Drug: Ascorbic acid"]}], "interventions"=>[{"name"=>"Ascorbic acid", "type"=>"DRUG", "description"=>"2 gm every 8hrs for 4 days", "armGroupLabels"=>["Control group", "Vitamin C group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11345", "city"=>"Cairo", "country"=>"Egypt", "facility"=>"Cairo university", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "overallOfficials"=>[{"name"=>"Mohamed Ashraf, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Cairo University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Lecturer of critical care", "investigatorFullName"=>"Mostafa Farouk", "investigatorAffiliation"=>"Cairo University"}}}}
