Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
In this prospective clinical study, the investigators compare the outcome and clinical course
 of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and
 thiamine (treatment group) with a control group treated in the investigators' ICU. The
 primary outcome is hospital survival. A propensity score is generated to adjust the primary
 outcome.There is 70 participants in each group.
A prospective randomized controlled trial is conducted.One hundred and forty severe sepsis or
 septic shock participants admit to the Department of Critical Care Medicine of Zhujiang
 Hospital,Southern Medical University from September 2017.The participants are divided into
 control group ( n = 70 ) and treatment group ( n = 70 ).The participants in both groups are
 treated according to "2016 international guidelines for management of sepsis and septic
 shock",and the participants in treatment group receive intravenous vitamin C, hydrocortisone,
 and thiamine. The participants in control group receive normal saline.The patients' clinical
 and demographic data, including age, sex, admitting diagnosis, comorbidities, requirement for
 mechanical ventilation, use of vasopressors, daily urine output, fluid balance after 24 and
 72 h, length of ICU stay (LOS),and laboratory data (serum creatinine, White Blood Cell (WBC),
 platelet count, total bilirubin, procalcitonin(PCT), and lactate levels), are recorded.The
 primary outcome is hospital survival. Secondary outcomes include duration of vasopressor
 therapy,requirement for renal replacement therapy in patients with Acute kidney injury (AKI),
 ICU LOS, and the change in serum procalcitonin and Sepsis-Related Organ Failure Assessment
 (SOFA score) over the first 72 h. Summary statistics are used to describe the clinical data
 and are presented as means±SD, medians and interquartile range, or percentages as
 appropriate.Statistical analysis is performed with NCSS 11 (NCSS Statistical Software) and
 SPSS Statistics version 24 (IBM).
Inclusion Criteria:

 -  A primary diagnosis of sepsis or septic shock (the diagnoses of sepsis and septic
 shock are based on the 2016 the Third International Consensus Definitions for Sepsis
 and Septic Shock (Sepsis-3)) and a procalcitonin (PCT) level≥2ng/mL.

 Sepsis: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated
 host response to infection.

 Septic shock: Septic shock is a subset of sepsis in which underlying circulatory and
 cellular/metabolic abnormalities are profound enough to substantially increase mortality.

 Exclusion Criteria:

 -  Patients < 18 years of age, pregnant patients, and patients with limitations of care.