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 10, 2018
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|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|
|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|
"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
- Hospital Mortality [ Time Frame: 90 days ]Death before hospital discharge
- 60-day mortality [ Time Frame: 60 days ]Death before day 60 post-randomization
- 28-day mortality [ Time Frame: 28 days ]Death before day 28 post-randomization
- 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
- 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%.
- 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
- Intensive Care Unit (ICU) mortality [ Time Frame: 90 days ]Death before ICU discharge
- 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
- ICU length of stay [ Time Frame: 90 days ]Duration of the need for intensive care after randomization
- Hospital length of stay [ Time Frame: 90 days ]Duration of hospitalization 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): NCT03592693
|Contact: Anastasia Kotanidou, MD, PHD, Professorfirstname.lastname@example.org|
|Contact: Spyros D Mentzelopoulos, MD, PHD, Associate Professoremail@example.com|
|Evaggelismos General Hospital||Recruiting|
|Athens, Attica, Greece, 10676|
|Contact: Anastasia Kotanidou, MD, PHD +306977077105 firstname.lastname@example.org|
|Contact: Spyros D Mentzelopoulos, MD, PHD +306975304909 email@example.com|
|General Hospital of Nikaia Saint Panteleimon||Not yet recruiting|
|Piraeus, Attica, Greece, 18454|
|Contact: Antonis C Mavrommatis, MD +30-6944371145 firstname.lastname@example.org|
|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|