The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|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
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|