Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03509350|
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Drug: Vitamin C Drug: Thiamine Drug: Hydrocortisone Drug: Vitamin C Placebo Drug: Thiamine Placebo Drug: Hydrocortisone Placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Multi-center, Randomized, Placebo-controlled, Double-blind, Adaptive Clinical Trial of Vitamin C, Thiamine and Steroids as Combination Therapy in Patients With Sepsis.|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||October 2021|
Experimental: Treatment Protocol
Participants randomized to the treatment protocol will receive the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
Drug: Vitamin C
Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Ascorbic acid
Intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Thiamine hydrochloride
Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Hydrocortisone sodium succinate
Placebo Comparator: Control Protocol
A placebo to match the VICTAS intervention will be administered for four days or until ICU discharge. During the treatment period, if an indication for steroids exist, the treating physicians are permitted to initiate open-label corticosteroid therapy based on local practice and international guidelines. If this occurs, the hydrocortisone/placebo will be withheld and subjects will be started on open-label corticosteroids.
Drug: Vitamin C Placebo
A placebo to match intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Placebo
Drug: Thiamine Placebo
A placebo to match intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Placebo
Drug: Hydrocortisone Placebo
A placebo to match intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. Steroids will be used when clinically indicated.
Other Name: Placebo
- Vasopressor and ventilator-free days (VVFD) [ Time Frame: Day 30 ]The primary outcome measure is VVFD at 30 days (+/-3 days) after randomization. Vasopressor and ventilator-free days will be determined by recording all start and stop days of these measures.
- Mortality at 30 days [ Time Frame: Day 30 ]The number of participants who did not survive until Day 30 will be compared between study arms.
- Delirium-free and coma-free days (DCFD) [ Time Frame: Day 14 ]Delirium and Coma-Free Days (DCFDs) is defined as the number of days between enrollment and day 14 the subject has a Richmond Agitation-Sedation Scale (RASS) -3 or higher and Confusion Assessment Method for the ICU (CAM-ICU) negative (or Brief Confusion Assessment Method (bCAM) negative if in the ED) among survivors at that time point (day 14). The RASS categorizes patient sedation level on a scale from -5 (unarousable sedation) to +4 (combative), where 0 indicates alert and calm. Delirium is diagnosed with the CAM when the patient exhibits an acute change in mental status and inattention plus either disorganized thinking or an altered level of consciousness.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509350
|Contact: Jonathan Sevransky, MD, MHSfirstname.lastname@example.org|
Show 43 Study Locations
|Principal Investigator:||Jonathan Sevransky, MD, MHS||Emory University|