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

March 10, 2019 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: vitamin C、hydrocortisone、thiamine
Intravenous vitamin C (1.5 g every 6 h for 4 days or until ICU discharge), hydrocortisone (50 mg every 6 h for 7 days or until ICU discharge followed by a taper over 3 days), as well as intravenous thiamine (200 mg every 12 h for 4 days or until ICU discharge).
Drug: Hydrocortisone, Vitamin C, and Thiamine
Intervention
PLACEBO_COMPARATOR: normal saline
Normal saline 500ml every day for 4 days，then 200ml every day for 3 days.
Other: Normal saline
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hospital survival
Time Frame: Up to Day 14
Up to Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of vasopressor therapy
Time Frame: Up to hour 72
Up to hour 72
requirement for renal replacement therapy in participants with Acute kidney injury(AKI)
Time Frame: Up to Day 14
Up to Day 14
ICU length of stay(LOS)
Time Frame: Up to Day 14
Up to Day 14
the change in serum procalcitonin (PCT)
Time Frame: Up to hour 72
Up to hour 72
Sepsis-Related Organ Failure Assessment(SOFA)score
Time Frame: Up to hour 96
Up to hour 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 25, 2017

Primary Completion (ACTUAL)

February 2, 2019

Study Completion (ACTUAL)

February 2, 2019

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 20, 2017

First Posted (ACTUAL)

August 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liao Yuping

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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