NCT03258684

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: A Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	Hydrocortisone, Vitamin C, and Thiamine	Intervention
OTHER	Normal saline	Placebo

Timeline

• Start date: 2017-09-25
• Primary completion: 2019-02-02
• Completion: 2019-02-02
• First posted: 2017-08-23
• Last updated: 2019-03-12

Locations

1 site across 1 country: China