Clinical trial NCT03258684: Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
Official title: Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: corticosteroid
hydrocortisone
septic shock
thiamine
vitamin C
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: hospital survival
timeFrame: Up to Day 14
Secondary outcomes:
measure: duration of vasopressor therapy
timeFrame: Up to hour 72
measure: requirement for renal replacement therapy in participants with Acute kidney injury(AKI)
timeFrame: Up to Day 14
measure: ICU length of stay(LOS)
timeFrame: Up to Day 14
measure: the change in serum procalcitonin (PCT)
timeFrame: Up to hour 72
measure: Sepsis-Related Organ Failure Assessment(SOFA)score
timeFrame: Up to hour 96
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
state: Guangdong
Study officials:
References:
citation: Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.
citation: Chang P, Liao Y, Guan J, Guo Y, Zhao M, Hu J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z. Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial. Chest. 2020 Jul;158(1):174-182. doi: 10.1016/j.chest.2020.02.065. Epub 2020 Mar 31.