Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03509350
Recruitment Status : Completed
First Posted : April 26, 2018
Results First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
The Marcus Foundation
Information provided by (Responsible Party):
Jonathan Sevransky, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Sepsis
Interventions Drug: Vitamin C
Drug: Thiamine
Drug: Hydrocortisone
Drug: Vitamin C Placebo
Drug: Thiamine Placebo
Drug: Hydrocortisone Placebo
Enrollment 501
Recruitment Details Participant enrollment began on August 22, 2018. Follow-up for the primary outcome measure was completed on August 22, 2019 and follow up for the secondary outcome measures was completed on January 29, 2020. Participants were recruited from multiple sites in the United States of America.
Pre-assignment Details  
Arm/Group Title Treatment Protocol Control Protocol
Hide Arm/Group Description Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge. Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
Period Title: Overall Study
Started 252 249
Completed 252 247
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Treatment Protocol Control Protocol Total
Hide Arm/Group Description Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge. Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge. Total of all reporting groups
Overall Number of Baseline Participants 252 249 501
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 249 participants 501 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
148
  58.7%
143
  57.4%
291
  58.1%
>=65 years
104
  41.3%
106
  42.6%
210
  41.9%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 252 participants 249 participants 501 participants
62
(51 to 69)
61
(50 to 72)
62
(50 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 249 participants 501 participants
Female
113
  44.8%
115
  46.2%
228
  45.5%
Male
139
  55.2%
134
  53.8%
273
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 249 participants 501 participants
Hispanic or Latino
32
  12.7%
24
   9.6%
56
  11.2%
Not Hispanic or Latino
211
  83.7%
215
  86.3%
426
  85.0%
Unknown or Not Reported
9
   3.6%
10
   4.0%
19
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 249 participants 501 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
70
  27.8%
80
  32.1%
150
  29.9%
White
149
  59.1%
135
  54.2%
284
  56.7%
More than one race
33
  13.1%
34
  13.7%
67
  13.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 252 participants 249 participants 501 participants
252
 100.0%
249
 100.0%
501
 100.0%
1.Primary Outcome
Title Vasopressor and Ventilator-free Days (VVFD)
Hide Description The primary outcome measure is VVFD in the first 30 days after the start of treatment. The endpoint will be recorded to the nearest day. Participants who die are scored zero days, even if there is a period during which the participant is alive and free of vasopressors and mechanical ventilation. Participants who must return to ventilation and/or vasopressors will have their counters reset at zero days.
Time Frame Up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis uses an intent-to-treat (ITT) analysis set, which includes all participants who enrolled in the study.
Arm/Group Title Treatment Protocol Control Protocol
Hide Arm/Group Description:
Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
Overall Number of Participants Analyzed 252 249
Median (Inter-Quartile Range)
Unit of Measure: days
25
(0 to 29)
26
(0 to 28)
2.Secondary Outcome
Title Mortality at 30 Days
Hide Description The number of participants who did not survive until Day 30 will be compared between study arms.
Time Frame Day 30
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Intensive Care Unit (ICU) Mortality
Hide Description The number of participants who die while in the ICU will be compared between study arms.
Time Frame Day 30
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Mortality at 180 Days
Hide Description The number of participants who did not survive until Day 180 will be compared between study arms.
Time Frame Day 180
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Length of ICU Stay
Hide Description The number of days in the ICU will be compared between study arms.
Time Frame Day 30
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Length of Hospital Stay
Hide Description The number of days in the hospital will be compared between study arms.
Time Frame Day 30
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Digit Span Test Score
Hide Description The digit span test will be used to assesses attention. Participants are read a series of numbers and are asked to repeat them back in the same order. The Digit Span test is scored by the amount of numbers the participant was able to remember in each test. Higher scores indicate greater ability to pay attention and to remember sequences.
Time Frame Day 180
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Delirium Telephone Confusion Assessment Method (CAM)
Hide Description The Telephone CAM evaluates dementia with 9-items, where additional questions are asked if symptoms are present. Rather than providing a summary score, if participants exhibit signs of a change in mental status which fluctuates and they experience inattention, along with disorganized thinking or altered level of consciousness, delirium is suggested.
Time Frame Day 180
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Hayling Test Score
Hide Description Executive function will be assessed with the Hayling Test. The Hayling Test includes two parts of 15 items each where participants complete sentences by providing the missing word. The test is scored as the amount of time it takes, in seconds, to recite a correct response and the appropriateness of the response (in Part 2). Scaled scores range from 1 to 10 where 1 = impaired, 6 = average, and 10 = very superior.
Time Frame Day 180
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Controlled Oral Word Association Test (COWAT) Score
Hide Description Language will be assessed with the Controlled Oral Word Association Test (COWAT). Participants generate words beginning with selected letters within 60 seconds. Generating a higher number of words indicates greater language skills.
Time Frame Day 180
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Wechsler Memory Scale IV - Paragraph Recall Score
Hide Description Memory will be assessed with the Paragraph Recall from the Wechsler Memory Scale IV. Participants listen to two short paragraphs and are asked to recall details from each story immediately and after 30 minutes. Scores represent the number of correctly remembered details. Total scores for each recall time period (immediate and after 30 minutes) range from 0 to 25 with higher scores reflecting better memory.
Time Frame Day 180
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Telephone Interview for Cognitive Status (TICS)
Hide Description The Telephone Interview for Cognitive Status (TICS) is an 11-item instrument assessing orientation. Correct responses to the items are scored in a variety of ways, depending on how much of the response is correct. Total scores range from 0 to 41 with higher scores indicating increased cognitive orientation.
Time Frame Day 180
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Wechsler Adult Intelligence Scale (WAIS)-IV Similarities Score
Hide Description Reasoning will be assessed with the WAIS-IV Similarities instrument. Participants are asked to explain how two words are alike. Responses are scored according to how correct they are, with a score of 0 for incorrect answers. After 3 consecutive scores of 0 the survey is stopped. Total raw scores vary depending on the number of word pairs presented. Higher scores indicate better performance. Scores will be compared between study arms.
Time Frame Day 180
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Katz Index of Independence in Activities of Daily Living (ADL) Score
Hide Description Activities of daily living will be assessed with the Katz ADL instrument. The Katz ADL has 6 items asking if participants can perform daily tasks independently. Responses are scored as 1 = yes and 0 = no. Total scores range from 0 to 6 with higher scores indicating greater independence.
Time Frame Day 180
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Employment Questionnaire
Hide Description The Employment Questionnaire is a brief measure of the participant's employment history and ability or capacity to work. There is not a summary score for this qualitative questionnaire.
Time Frame Day 180
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Functional Activities Questionnaire (FAQ) Score
Hide Description Instrumental activities of daily living will be assessed with the Functional Activities Questionnaire (FAQ). The FAQ includes 10 items which are scored on a scale from 0 to 3 where 0 = normal and 3 = dependent. Total scores range from 0 to 30 and lower scores indicate that the respondent is able to perform daily activities. A score of 9 (where the person is dependent in 3 activities) is used as a cut-point indicating impairments with functioning.
Time Frame Day 180
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6
Hide Description Depression will be assessed with the PROMIS Depression 6 instrument. This tool includes 6 items with response options on a scale of 1 to 5. Total raw scores range from 6 to 30 with higher scores indicating greater symptoms of depression.
Time Frame Day 180
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Posttraumatic Stress Disorder - 8 (PTSD-8)
Hide Description Posttraumatic Stress Disorder (PTSD) will be assessed with the Posttraumatic Stress Disorder - 8 instrument. The PTSD-8 includes 8 items which are answered on a 4 point scale where 1 = not at all and 4 = all of the time. Total scores range from 8 to 32 where higher scores indicate greater symptoms of PTSD.
Time Frame Day 180
Outcome Measure Data Not Reported
19.Secondary Outcome
Title EuroQol, 5 Dimension (EQ5D)
Hide Description Quality of life will be assessed with the EuroQol, 5 dimension (EQ5D) questionnaire. The EQ5D asks about 5 dimensions of health (mobility, self-care, usual activities, pain, and depression). These 5 items are assessed on a scale from 1 to 5 where 1 =no problems and 5 = extremely problematic. Total raw scores range from 5 to 25 where higher scores indicate lower quality of life. The questionnaire also includes a visual analog scale where respondents rate their current health; 0 = worst health imaginable and 100 = best health imaginable.
Time Frame Day 180
Outcome Measure Data Not Reported
Time Frame Adverse events potentially associated with the study treatment and serious adverse events were monitored from the time of randomization up to Day 30.
Adverse Event Reporting Description Adverse events that were not considered serious or potentially associated with the treatment were not recorded.
 
Arm/Group Title Treatment Protocol Control Protocol
Hide Arm/Group Description Participants randomized to the treatment protocol received the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge. Participants in the control group received a placebo to match the VICTAS intervention, which was administered for four days or until ICU discharge.
All-Cause Mortality
Treatment Protocol Control Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   56/252 (22.22%)      60/249 (24.10%)    
Hide Serious Adverse Events
Treatment Protocol Control Protocol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/252 (0.00%)      0/249 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Protocol Control Protocol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/252 (0.79%)      0/249 (0.00%)    
Blood and lymphatic system disorders     
Hemorrhagic shock due to hemolysis *  1/252 (0.40%)  1 0/249 (0.00%)  0
Renal and urinary disorders     
Worsening of renal function *  1/252 (0.40%)  1 0/249 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jon Sevransky MD, MHS
Organization: Emory University
Phone: 404-778-5734
EMail: jonathan.sevransky@emoryhealthcare.org
Layout table for additonal information
Responsible Party: Jonathan Sevransky, Emory University
ClinicalTrials.gov Identifier: NCT03509350    
Other Study ID Numbers: IRB00102528
IRB00164053 ( Other Identifier: Johns Hopkins IRB )
First Submitted: April 10, 2018
First Posted: April 26, 2018
Results First Submitted: August 22, 2020
Results First Posted: September 18, 2020
Last Update Posted: September 18, 2020