The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
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|ClinicalTrials.gov Identifier: NCT03335124|
Recruitment Status : Terminated (Due to insufficient recruitment)
First Posted : November 7, 2017
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Septic Shock Critical Illness Fluid Overload||Drug: Vitamin C Drug: Hydrocortisone Drug: Thiamine Drug: 0.9% Sodium Chloride Injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomized, Double Blind, Placebo-Controlled Study to Investigate the Effects of Vitamin C, Hydrocortisone and Thiamine on the Outcome of Patients With Severe Sepsis and Septic Shock|
|Actual Study Start Date :||September 26, 2017|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
Experimental: Active substances
Vitamin C: Vitamin C will be mixed as 1500 mg vitamin C in 50ml container, which will then be infused over 30 minutes to 1 hour. The bag will be labeled by the pharmacy as Vitamin C. The dosing schedule is 1500mg every 6 hours for 4 days or until discharge from the ICU.
Hydrocortisone: Hydrocortisone will be mixed as 50 mg of Hydrocortisone in 50 ml of 0.9 % Sodium Chloride. Patients will be treated with hydrocortisone 50mg IV q 6 hourly for 4 days or until ICU discharge.
Thiamine: Intravenous thiamine will be given in a dose of 200mg q 12 hourly for 4 days or until ICU discharge.
Drug: Vitamin C
Vitamin C: Vitamin C will be applied as per instructions described in arm/group descriptions.
Other Name: Ascorbic Acid
Hydrocortisone: Hydrocortisone will be applied as per instructions described in arm/group descriptions.
Other Name: Corticosteroids
Intravenous thiamine will be applied as per instructions described in arm/group descriptions.
Other Name: B1 Vitamin
Placebo Comparator: Control
Vitamin C placebo will consist of an identical container of 50cc normal saline (0.9% Sodium Chloride Injection) (but with no vitamin C) and will be labelled vitamin C. Placebo will be infused over 30-60 minutes as per the infusion instructions of the active vitamin. Hydrocortisone placebo will be provided in an identical 50 ml bag of 0.9% Sodium Chloride Injection. Placebo patients will receive a matching vial of 0.9% Sodium Chloride Injection.
Drug: 0.9% Sodium Chloride Injection
0.9 % Sodium Chloride will be applied as placebo as per instructions described in arm/group descriptions.
Other Name: Normal Saline
- Hospital mortality [ Time Frame: From date of randomization till time of discharge, assessed up to 12 months ]We will compare mortality between the treatment and placebo groups during the hospitalization
- 60 day mortality [ Time Frame: 60 days from inclusion in the study ]We will compare mortality between the treatment and placebo groups after 60 days after inclusion in the study
- 28 day mortality [ Time Frame: 28 days from inclusion in the study ]We will compare mortality between the treatment and placebo groups after 28 days after inclusion in the study
- Time to vasopressor independence [ Time Frame: Defined as the time from starting the active treatment/placebo to discontinuation of all pressors, till discharged from ICU, assessed in the first month ]Defined as the time from starting the active treatment/placebo to discontinuation of all pressors
- PCT clearance [ Time Frame: The first 4 days in Intensive Care Unit ]Clearance of calculated procalcitonin using the following formula: initial PCT minus PCT at 96 hours, divided by the initial PCT multiplied by 100.
- Delta SOFA score [ Time Frame: The first 4 days in Intensive Care Unit ]Delta Systemic Organ Failure Assesment score, defined as the initial SOFA score minus the day 4 SOFA score. The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The higher the value, the higher the mortality. The maximum score is 24, the lowest 0.
- ICU length of stay (LOS) and ICU free days. [ Time Frame: ICU free days is calculated as the number of days alive and out of the ICU to day 28 ]ICU free days is calculated as the number of days alive and out of the ICU to day 28
- Hospital Length of Stay [ Time Frame: Hospital Length of Stay through the study completion, assessed up to 12 months ]The length of stay in the hospital
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): NCT03335124
|Department of Gastroenterology, UMC Ljubljana|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Sebastian Stefanovic, MD||University Medical Center Ljubljana, Department of Gastroenterology|