Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock

Sepsis Clinical Trial

— HYVCTTSSS  

Official title:

Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258684
• Other study ID #: Liao Yuping
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: February 2, 2019

Study information

• Verified date: January 2019
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2, 2019
• Est. primary completion date: February 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Shock, Septic
• Toxemia

Intervention

Drug:
• Hydrocortisone, Vitamin C, and Thiamine
Intervention

Other:
• Normal saline
Placebo

Locations

Country	Name	City	State
China	Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital survival		Up to Day 14
Secondary	duration of vasopressor therapy		Up to hour 72
Secondary	requirement for renal replacement therapy in participants with Acute kidney injury(AKI)		Up to Day 14
Secondary	ICU length of stay(LOS)		Up to Day 14
Secondary	the change in serum procalcitonin (PCT)		Up to hour 72
Secondary	Sepsis-Related Organ Failure Assessment(SOFA)score		Up to hour 96

External Links

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