[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503985":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":92,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":25,"enrollmentInfo":108,"targetDuration":25,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Clinical Research Centre, Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IV Vitamin C (12g\u002Fday)","EXPERIMENTAL","IV Vitamin C 3g diluted with dextrose 5% into 50ml, given every 6 hourly (12g\u002Fday), infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses).",[13],"Drug: Active Ingredient",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","IV dextrose 5% 50ml, given every 6 hourly, infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses).",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":9,"armGroupLabels":24,"otherNames":25},"DRUG","Active Ingredient",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"IV dextrose 5%",[15],[30],{"name":31,"affiliation":32,"role":33},"Calvin Wong Ke Wen, MBBS MRCP","Hospital Umum Sarawak, Malaysia","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+6082276 666","vicsep.my@gmail.com",[40,60,76],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital Sultanah Bahiyah","RECRUITING","Alor Star","Kedah","05460","Malaysia","MY",{"type":49,"coordinates":50},"Point",[51,52],100.36014,6.12104,{"lat":52,"lon":51},[55,58],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":25},"Asmah Zainudin","+6047406233",{"name":59,"role":33,"phone":25,"phoneExt":25,"email":25},"Asmah Zainudin, MBBS MMED",{"facility":61,"status":42,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Hospital Raja Perempuan Zainab II","Kota Bharu","Kelantan","15200",{"type":49,"coordinates":66},[67,68],102.24333,6.12361,{"lat":68,"lon":67},[71,74],{"name":72,"role":36,"phone":73,"phoneExt":25,"email":25},"Wan Nasrudin Wan Ismail","+6097452000",{"name":75,"role":33,"phone":25,"phoneExt":25,"email":25},"Wan Nasrudin Wan Ismail, MD MMED FCICM",{"facility":77,"status":42,"city":78,"state":79,"zip":80,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hospital Raja Permaisuri Bainun","Ipoh","Perak","30450",{"type":49,"coordinates":82},[83,84],101.0829,4.5841,{"lat":84,"lon":83},[87,90],{"name":88,"role":36,"phone":89,"phoneExt":25,"email":25},"Cheah Pike Kuan","+6052085000",{"name":91,"role":33,"phone":25,"phoneExt":25,"email":25},"Cheah Pike Kuan, MD MMED",{"type":93,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[95],{"name":96,"class":97},"Ain Medicare Sdn Bhd","UNKNOWN","100503985","phase-2-effect-of-high-dose-intravenous-vitamin-c-in-severe-pneumonia-100503985",false,"NCT05842382","Effect of High Dose Intravenous Vitamin C in Severe Pneumonia","Effect of High Dose Intravenous Vitamin C as an Adjunct in the Treatment of Patients With Severe Pneumonia in Intensive Care Unit: a Multi-center, Double-blinded, Two-arm, Placebo-controlled, Randomized Trial","VICSEP","Inclusion Criteria:\n\n* Patients who are aged 18 and above\n* Patients who are diagnosed with severe pneumonia\n* Patients who are mechanically ventilated\n\nExclusion Criteria:\n\n* Known allergy to Vitamin C\n* Pregnancy\n* Known history of ongoing concomitant infection\n* Participation in another clinical trial and\u002For receipt of investigational drugs within 4 weeks prior to enrollment\n* Moribund patient with multiorgan failure to the judgement of the treating physician, who is not expected to survive 24 hours\n* Patient who requires home oxygen therapy or mechanical ventilation, including tracheostomy or non-invasive ventilation, except for CPAP\u002FBIPAP for sleep-disordered breathing\n* Known history of previous or current diagnosis of renal stones\n* Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* Known diagnosis of hemochromatosis\n* Known diagnosis of poorly controlled chronic pulmonary disease, including:\n\n  * Chronic obstructive pulmonary disease with oxygen therapy\n  * Chronic restrictive pulmonary disease with oxygen therapy\n  * Bronchial asthma on Step 5 of treatment ladder as shown in Pocket Guide for Asthma Management and Prevention\n  * Lung cancer in Stage IV of disease\n* Known diagnosis of heart failure on anti-failure treatment or requiring mechanical hemodynamic support (e.g. LVAD), with recent hospitalization within 3 months (90 days) from the date of current admission.\n* Immunocompromised state\n* Known diagnosis of malignancy and ongoing chemotherapy or radiotherapy as there is evidence that antioxidant supplement before and during treatment was associated with an increased hazard of recurrence\n* Known diagnosis of malignancy who had completed chemotherapy or radiotherapy with absolute neutrophil count ≤100 cells\u002Fmm3\n* Known diagnosis of Stage 4 and above chronic kidney disease (GFR \\\u003C30 ml\u002Fmin\u002F1.73m2) and end-stage renal disease on regular dialysis (including peritoneal dialysis or hemodialysis)\n* Known history of renal transplantation\n* Absence of family members or next of kin for informed consent","ALL","18 Years",{"count":109,"type":110},484,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","This trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU.",[116],"Pneumonia",[118,119,120,121,122,123],"Severe pneumonia","Critically ill","Ascorbic acid","Vitamin C","Mechanical ventilation","Ventilation-free day","2024-06-17",{"date":126,"type":127},"2024-06-20","ACTUAL",{"date":129,"type":127},"2024-01-12",{"date":131,"type":110},"2026-02",{"name":5,"class":6},3]