Investigating the effects of zinc sulfate and vitamin C supplementation in sepsis management in septic patients

Evaluation of the effects of vitamin C and zinc supplementation on mortality rate in patients with sepsis

This is a randomized, double-blinded, parallel, two-armed, Single Center, Phase 3 clinical trial. Randomization will be done with block randomization method by the use of www.sealedenveloped.com. 60 patients with eligible criteria, will enrolled in study and randomly assigned to either intervention or control group.

Patients who will admitted to Baqiatallah hospital and will meet the eligible criteria, will be enrolled to study, and will randomly assigned in either intervention or placebo group, and will receive the drug/placebo for 10 days. This study is a double-blinded clinical trial, in which prescribed physician and statistical analyzer will be unaware of type of intervention.

Inclusion criteria: Having suspected or proven infections; Increasing 2 points or more in SOFA compared to baseline; The patient or his/her guardian has informed and free written consent to participate in the study. Exclusion criteria: Multi organ dysfunction; Glasgow Coma Score (GCS) less than 4; The patient needs emergency dialysis due to severe acidosis or end stage renal disease; Pregnancy; Breastfeeding; Being NPO for any reasons; Having kidney stones as his/her medical history; Having hypersensitivity reactions history with the intervention.

Intervention group : sachet contains 300 mg of vitamin C and 10 mg of zinc (produced by "Bonyan-Salamat-Kasra" company); every 12 hours, 7 sachet, per oral, for 10 days. Control group : Placebo sachet with Placebo sachet with a appearance quite similar to the original drug, every 12 hours, 7 sachet, per oral, for 10 days.

Mortality rate

Block randomization method is used for randomization (To do this, go to www.sealedenvelope.com and select the randomization tab and then create a list). Due to the two arms of the study and the sample size, the size of the blocks will be considered as 4, and finally a random list of how the patients are arranged in the two groups will be provided 2 groups .

This is a double-blind study in which the prescribing physician and statistical analyzer will unaware of the type of intervention (placebo or drug). The prepared placebo is completely similar in appearance to the main medicine.