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IRCT20190312043030N1 IRCT 2019-08-26 Tabriz University of Medical Sciences Effect of Vit C in severe pneumonia Effects of Vitamin C administration in patients mortality with severe pneumonia in ICU 2019-05-15 anticipated 80 Complete https://irct.ir/trial/39543 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 20 units of 4 blocks will be selected so that we consider having 40 people in control group (A) and 40 people in intervention group (B). Therefore, we will do block randomization, Blinding description: In this study, patients, clinical caregivers, and data analyzers will not aware of grouping . 3 Effects of vitamin C administration in patients mortality with severe pneumonia in ICU. Intervention 1: Intervention group:The recipient group will receive standard and routine pneumonia treatments including respiratory support and serum therapy and mechanical ventilation, empirical antibiotic therapy and subsequent antibiotic therapy with appropriate dose based on the results of cultures and relevant antibiograms, respectively, for 14 days. Appropriate doses of bronchodilator (salbutamol) and inhaled anticholinergic (Ipratropium bromide) mucolytic therapy (ampoule n-acetylcysteine) will also be used to treat these patients in addition to vitamin C (50mg / kg). The prescribed dose of Vitamin C 50mg / kg / day will be divided into 4 equal doses, each administered at 6 hours interval for 30 minutes at 50 ml DW5 serum (which will be included in the patient's serum intake) will continue for 4 days. Intervention 2: Control group:Group who will receive standard and routine pneumonia treatments including respiratory support and serum therapy and mechanical ventilation, emprical antibiotic therapy and subsequent antibiotic therapy with appropriate dose based on the results of cultures and relevant antibiograms, respectively, for 14 days. Appropriate doses of bronchodilator (salbutamol) and inhaled anticholinergic (Ipratropium bromide) mucolytic therapy (ampoule n-acetylcysteine) will also be used to treat these patients in addition to the same volume of normal saline in intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr.Seyed Hadi Saghaleini
East Azerbaijan Province, Tabriz, North West Medical Toxicology Center,Sina Hospital
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3541 2101 hsaghaleini@gmail.com Tabriz University of Medical Sciences scientific Dr.Seyed Hadi Saghaleini
East Azerbaijan Province, Tabriz, North West Medical Toxicology Center,Sina Hospital
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3541 2101 hsaghaleini@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) All patients who have been diagnosed with severe pneumonia criteria 18 years 90 years Both Patients who are not able to survive for more than 24 hours because of end-stage or clinical deterioration Patients with their own dissatisfaction or the inability to obtain informed consent from the patient or family of patients Patients under the age of 18 and over Patients who have had warfarin use 24 hours before study Patients who received up to 48 hours prior to admission Undetermined vitamin C Patients with bleeding disorders Patients with G6PD deficiency Patients with primary creatinine above 1.5 Patients with a history of kidney oxalate stones A40.3 Sepsis due to Streptococcus pneumoniae Treatment - Drugs Treatment - Drugs Intervention group:The recipient group will receive standard and routine pneumonia treatments including respiratory support and serum therapy and mechanical ventilation, empirical antibiotic therapy and subsequent antibiotic therapy with appropriate dose based on the results of cultures and relevant antibiograms, respectively, for 14 days. Appropriate doses of bronchodilator (salbutamol) and inhaled anticholinergic (Ipratropium bromide) mucolytic therapy (ampoule n-acetylcysteine) will also be used to treat these patients in addition to vitamin C (50mg / kg). The prescribed dose of Vitamin C 50mg / kg / day will be divided into 4 equal doses, each administered at 6 hours interval for 30 minutes at 50 ml DW5 serum (which will be included in the patient's serum intake) will continue for 4 days Control group:Group who will receive standard and routine pneumonia treatments including respiratory support and serum therapy and mechanical ventilation, emprical antibiotic therapy and subsequent antibiotic therapy with appropriate dose based on the results of cultures and relevant antibiograms, respectively, for 14 days. Appropriate doses of bronchodilator (salbutamol) and inhaled anticholinergic (Ipratropium bromide) mucolytic therapy (ampoule n-acetylcysteine) will also be used to treat these patients in addition to the same volume of normal saline in intervention group. Frequency of mortality. Timepoint: 28 days mortality rate. Method of measurement: Sequential organ failure Assessment score. Tabriz University of Medical Sciences Approved 2019-07-30 Ethic Committee of Tabriz University of Medical Sciences Tabriz University of Medical Science, Gholghasht street, Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)