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Vitamin C, Hydrocortisone and Thiamine for Septic Shock (CORVICTES)

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ClinicalTrials.gov Identifier: NCT03592693
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
General Hospital of Nikaia “Saint Panteleimon”
Naval Hospital, Athens
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens

Brief Summary:
Prior data has shown that both corticosteroids and vitamin C reduce the activation of nuclear factor ƘB (NFƘB), thereby ultimately attenuating the systemic inflammatory response to sepsis/septic shock and augmenting the responsiveness to vasopressors. Therefore, the current investigators hypothesized that the combined use of vitamin C and stress-dose hydrocortisone may improve the outcomes of patients with septic shock. The investigators intend to perform a randomized, multicenter, parallel group, double-blind, placebo-controlled trial of vitamin C plus stress-dose hydrocortisone or placebo plus placebo for a total of four days after randomization of patients fulfilling the current consensus criteria for septic shock. The primary outcome will be hospital mortality, whereas the scondary outcomes will include 60-day, 28-day mortality, time to vasopressor cessation, procalcitonin clearance and change in the Sequential Organ Failure Assessment score over the first 4 days after randomization, neurologic failure-free days, and length of stay in the intensive care unit (ICU) and the hospital. Target enrollment will be 400 patients.

Condition or disease Intervention/treatment Phase
Shock, Septic Drug: Combined Vitamin C and Stress-Dose Hydrocortisone Drug: Placebo plus placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, multicenter, parallel group, placebo-controlled [Vitamin c plus hydrocortisone or placebo plus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, Investigators performing the follow-up, and care providers will be blinded
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled Trial to Investigate the Effect of Vitamin C, Hydrocortisone and Thiamine on the Outcome of Patients With Septic Shock
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Vitamin-Steroid
"Combined Vitamin C and Stress-Dose Hydrocortisone": Patients with septic shock treated with 1500 mg Vitamin C every 6 hours for 4 days after randomization, and stress-dose hydrocortisone for 4 days (250 mg on day 1; and 200 mg on days 2, 3, and 4) after randomization.
Drug: Combined Vitamin C and Stress-Dose Hydrocortisone
Treatment of septic shock with vitamin C and stress-dose hydrocortisone aimed at the attenuation of the systemic inflammatory response and the improvement of vasopressor responsiveness.
Other Name: Vitamin-Steroid

Placebo Comparator: Control
"Placebo plus placebo:" Patients with septic shock treated with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone) for 4 days after randomization.
Drug: Placebo plus placebo
Treatment of septic shock with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone).
Other Name: Pacebo




Primary Outcome Measures :
  1. Hospital Mortality [ Time Frame: 90 days ]
    Death before hospital discharge


Secondary Outcome Measures :
  1. 60-day mortality [ Time Frame: 60 days ]
    Death before day 60 post-randomization

  2. 28-day mortality [ Time Frame: 28 days ]
    Death before day 28 post-randomization

  3. Procalcitonin (PCT) clearance . [ Time Frame: 4 days ]
    Will be defined as baseline PCT minus PCT at 96 hours post-randomization, divided by the initial PCT and multiplied by 100

  4. Delta Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 4 days ]

    Will be defined as the initial Sequential Organ Failure Assessment (SOFA) score minus the day 4 post-randomization SOFA score.

    The SOFA score is the sum of 6 subscores that range from 0 to 4 and provide an assessment of the function of the following organs/systems: Respiratory, Nervous, Cardiovascular, Liver, Coagulation, and Renal. An increasing SOFA subscore (from 0 to 1, 2, 3, and 4) indicates worsening function culminating into failure of the corresponding organ/system. The maximum possible total SOFA score equals to 24. A SOFA score of 15 or more has been previously associated with a mortality rate of more than 90%.


  5. Neurologic failure-free days (defined as daily follow-up Glasgow Coma Score >9) within the first 28 days of follow-up [ Time Frame: 28 days ]
    Will be defined as the number of days with a (daily) follow-up Glasgow Coma Score >9 within the first 28 days of follow-up

  6. Intensive Care Unit (ICU) mortality [ Time Frame: 90 days ]
    Death before ICU discharge

  7. ICU free days to day 28. [ Time Frame: 28 days ]
    Will be defined as the number of days alive and out of the ICU until follow-up day 28

  8. ICU length of stay [ Time Frame: 90 days ]
    Duration of the need for intensive care after randomization

  9. Hospital length of stay [ Time Frame: 90 days ]
    Duration of hospitalization after randomization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • i. Diagnosis of septic shock within 12 hours of admission to the ICU

Exclusion Criteria:

  • i. Age < 18 years ii. Pregnant iii. Patients with an end-stage underlying disease who are unlikely to survive to hospital discharge iv. Patients with acquired immunodeficiency syndrome and a CD4 count of < 50 per microliter v. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency. vi. Patients with septic shock transferred from another hospital vii. Patients with septic shock for more than 12 hours viii. Patients who require off-label treatment with corticosteroids for an indication other than sepsis ix. Lack of written, informed consent

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): NCT03592693


Contacts
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Contact: Anastasia Kotanidou, MD, PHD, Professor +306977077105 akotanid@gmail.com
Contact: Spyros D Mentzelopoulos, MD, PHD, Associate Professor +306975304909 sdmentzelopoulos@yahoo.com

Locations
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Greece
Evaggelismos General Hospital Recruiting
Athens, Attica, Greece, 10676
Contact: Anastasia Kotanidou, MD, PHD    +306977077105    akotanid@gmail.com   
Contact: Spyros D Mentzelopoulos, MD, PHD    +306975304909    sdmentzelopoulos@yahoo.com   
General Hospital of Nikaia Saint Panteleimon Not yet recruiting
Piraeus, Attica, Greece, 18454
Contact: Antonis C Mavrommatis, MD    +30-6944371145    mavro58@yahoo.gr   
Sponsors and Collaborators
University of Athens
General Hospital of Nikaia “Saint Panteleimon”
Naval Hospital, Athens
Investigators
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Principal Investigator: Anastasia Kotanidou, MD, PHD, Professor National and Kapodestrian University of Athens, Greece
Principal Investigator: Spyros D Mentzelopoulos, MD, PHD, Associate Professor National and Kapodestrian University of Athens, Greece
Study Director: Stylianos Orfanos, MD, PHD, Professor National and Kapodestrian University of Athens, Greece
Study Chair: Spyros G Zakynthinos, MD, PHD, Professor National and Kapodestrian University of Athens, Greece

Publications:
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Responsible Party: Spyros D. Mentzelopoulos, Associate Professor of Intensive Care Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT03592693     History of Changes
Other Study ID Numbers: 236-16-10-2017
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no IPD sharing plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spyros D. Mentzelopoulos, University of Athens:
Shock, Septic
Vitamin C
Hydrocortisone
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
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