The Effect of Hydrocortisone-Ascorbic Acid and Thiamine Therapy on the Outcome of Patients with Sepsis: Prospective Randomized Double-Blinded Controlled Trial

Abstract

Background: Millions of individuals worldwide suffer from septic shock and sepsis each year, with fatalities reaching one in four and often higher. This work was conducted to evaluate the impact of Ascorbic acid, hydrocortisone, and thiamine treatment on the 28th day mortality rate and the outcomes (changes in SOFA score, incidence of organ dysfunction, alterations in serum procalcitonin level, changes in serum lactate level and total dose of vasopressor therapy. Methods: This prospective randomised controlled double-blinded work was performed on 80 individuals ranging in age from 18 to 65 years old and presented with sepsis who were diagnosed based on the SSC 2016 and The SSC Bundle 2018 Update. The participants were divided into two groups at random. Group I (placebo): The conventional approach was used to treat those who were in this group. The participants were given 50 ml of normal saline intravenously within 30 minutes, 5 ml intravenously within 6 hours, and 10 ml intravenously within 12 hours. Group II: the participants had standard sepsis treatment as well as a combination of ascorbic acid 1.5 gm diluted in 50 ml of normal saline IV within 30 minutes of 6 hours and thiamine 200 mg diluted in 10 ml of normal saline IV over a 12-hour period. If the admission term was shorter than 4 days, this combination treatment was provided until the time of release for a total of 4 days. Results: No statistically substantial variation was existed among both groups as regard incidence of 28th day mortality and incidence of organ dysfunction. At day one, the comparison of the mean values of mean arterial pressure (MAP) and cardiac index was comparable between the two groups. At day 2,3 and 4, the mean values of MAP were greater in group II in contrast to group I while cardiac index was greater in group I compared to group II. The mean value (± SD) of the total dose of noradrenaline was 824.1 ± 296.8 mg in group I, and 591.9 ± 343.2 mg in group II, with statistically substantial variation among the two groups (P<0.001) Conclusions: The combined use of ascorbic acid, thiamine, and hydrocortisone has no impact on the 28th day mortality and organ dysfunction among individuals with septic shock and sepsis but has a good impact on haemodynamic parameters and inflammatory markers during the period of drug administration.