Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258684
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Hydrocortisone, Vitamin C, and Thiamine Other: Normal saline Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock: A Prospective Study
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : February 2, 2019
Actual Study Completion Date : February 2, 2019


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




Primary Outcome Measures :
  1. hospital survival [ Time Frame: Up to Day 14 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258684


Locations
Layout table for location information
China, Guangdong
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03258684     History of Changes
Other Study ID Numbers: Liao Yuping
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhujiang Hospital:
corticosteroid
hydrocortisone
septic shock
thiamine
vitamin C
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Vitamins
Ascorbic Acid
Thiamine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Inflammatory Agents
Vitamin B Complex