Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock (CORVICTES-ΥΜ)
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|ClinicalTrials.gov Identifier: NCT03649633|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Stress-dose Hydrocortisone plus Vitamin C Drug: isotonic sodium chloride solution placebo plus isotonic sodium chloride solution placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-center, prospective, randomized, doubleblind, placebo-controlled, parallel-group clinical trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Participant, Care Provider, Investigator, Outcomes Assessor|
|Official Title:||Effect of Combined Vitamin C, Stress-dose Steroids, and Thiamine on Cerebral Autoregulation and Functional Outcomes of Patients With Septic Shock|
|Actual Study Start Date :||September 6, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Steroids/Vitamin C group
"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: Stress-dose Hydrocortisone plus Vitamin C
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 group
"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: isotonic sodium chloride solution placebo plus isotonic sodium chloride solution placebo
Treatment of septic shock with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone).
Other Name: Placebo-placebo
- Cerebral autoregulation [ Time Frame: 24-78 hours after randomization ]Cerebral autoregulation while increasing MAP from a minimum of 65-75 mmHg to a maximum of 90-100 mmHg by changing the vasopressor infusion rate.
- Cerebral blood flow [ Time Frame: 24-78 hours after randomization ]Cerebral blood flow at an MAP of 65-75 mmHg and an MAP of 90-100 mmHg
- Neurologic failure free days [ Time Frame: Days 1-60 after randomization ]Neurologic failure free days from day 1 to day 60 postrandomization; patients with a Glasgow Coma Scale Score of more than 9 will be considered as neurologic failure-free.
- Ventilator-free days [ Time Frame: Days 1-60 after randomization ]Ventilator-free days from day 1 to day 60 postrandomization; on any given follow-up day, patients will be considered as ventilator-free only in the absence of any need for ventilatory support within the preceding 24 hours.
- Favorable, Inhospital, Neurological Outcome [ Time Frame: Days 1-60 after randomization ]Survival to hospital discharge with a Cerebral Performance Category Score (CPC) of 1 or 2. The CPC score has 5 categories: 1 = good cerebral performance: the patient is conscious, alert, and able to work and lead a normal life; 2 = moderate cerebral disability: the patient is conscious and capable of independent activities of daily life; disorders such as hemiplegia, seizures, ataxia, cognitive changes, and/or noncerebral organ dysfunction causing moderate disability may be present; 3 = severe cerebral disability: patient is conscious and ambulatory but dependent on others, because of severe memory disturbance or dementia, or patient is paralyzed and can communicate only with his/her eyes, as in the locked-in syndrome; severe disability from noncerebral organ dysfunction may coexist; 4 = coma or vegetative state: patient is unconscious and unable of any verbal and/or psychological interaction with the environment; and 5 = death: certified brain death.
- Patient-reported health-related quality of life: SF-36 [ Time Frame: 90 days after randomization ]
Patient-reported health-related quality of life by using the Short Form-36 Quality of Life questionnaire; available from: https://repository.niddk.nih.gov/static/studies/halt-pkd/Forms/F038%20Quality%20of%20Life.pdf; https://www.optum.com/campaign/ls/outcomes-survey-request.html.
The Short Form 36 Quality of Life Questionnaire is a validated, 36-item, generic health status measure with scales of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, and reported health transition. The questionnaire is scored according to a norm-based scoring method. For example, assuming that an average normal person has a score of 50 in each scale, an individual respondent scoring below 45 is considered to have a "below-average" health status.
- Biomarkers [ Time Frame: 24-72 hours after randomization ]Plasma levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta (1β), IL-6, IL-8, IL-10, Neuron Specific Enolase, and protein S100B at 24, 48, and 72 hours after randomization.
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): NCT03649633
|Contact: Spyros D Mentzelopoulos, MD, PhDemail@example.com|
|Contact: Spyros G Zakynthinos, MD, PhDfirstname.lastname@example.org|
|Evaggelismos General Hospital||Recruiting|
|Athens, Attica, Greece, 10676|
|Contact: Spyros D Mentzelopoulos, MD, PhD +306975304909 email@example.com|
|Principal Investigator: Spyros D Mentzelopoulos, MD, PhD|
|Principal Investigator: Anastasia Kotanidou, MD, PhD|
|Sub-Investigator: Sotirios Malachias, MD, PhD|
|Principal Investigator:||Spyros D Mentzelopoulos, MD, PhD||University of Athens Medical School|
|Principal Investigator:||Anastasia Kotanidou, MD, PhD||University of Athens Medical School|
|Study Director:||Stylianos Orfanos, MD, PhD||University of Athens Medical School|
|Study Chair:||Spyros G Zakynthinos, MD. PhD||University of Athens Medical School|