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Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock (CORVICTES-ΥΜ)

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Stress-dose Hydrocortisone plus Vitamin C
isotonic sodium chloride solution placebo plus isotonic sodium chloride solution placebo
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Shock, Septic, Cerebrovascular Circulation, Spectroscopy, Near-Infrared, Patient Reported Outcome Measure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Diagnosis of septic shock within 12 hours of admission to the intensive care unit (ICU).

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Patients with a fatal underlying disease who are unlikely to survive to hospital discharge
  • Patients with acquired immunodeficiency and a CD4 count of < 50 / μL
  • Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.
  • Patients with sepsis/septic shock transferred from another hospital
  • Patients with features of sepsis/septic shock > 12 hours
  • Patients who require treatment with corticosteroids for an indication other than sepsis
  • Patients with any history of an allergic reaction

Sites / Locations

  • Evaggelismos General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Steroids/Vitamin C group

Control group

Arm Description

"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.

"Placebo plus placebo:" Patients with septic shock treated with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone) for 4 days after randomization.

Outcomes

Primary Outcome Measures

Cerebral autoregulation
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
Cerebral blood flow at an MAP of 65-75 mmHg and an MAP of 90-100 mmHg

Secondary Outcome Measures

Neurologic failure free days
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
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
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
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
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.

Full Information

First Posted
August 24, 2018
Last Updated
May 8, 2023
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03649633
Brief Title
Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock
Acronym
CORVICTES-ΥΜ
Official Title
Effect of Combined Vitamin C, Stress-dose Steroids, and Thiamine on Cerebral Autoregulation and Functional Outcomes of Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study has been approved as a nested substudy of a multicenter trial (CORVICTES, Clinicaltrials.gov Identifier: NCT03592693). The current, randomized, placebo-controlled study will compare steroids/vitamin C versus placebo/placebo in septic shock, with respect to cerebral autoregulation, biomarkers, and functional outcome. The following hypotheses will be tested: The steroids/vitamin C/thiamine intervention may result in attenuation of the septic shock-associated impairment in cerebral autoregulation; and 2) The increased frequency of intact cerebral autoregulation in the intervention group may result in more neurologic failure free days and ventilator free days during a 60-day follow-up; improved survival to hospital discharge with good functional outcome; and better patient-reported health-related outcomes at 90-day follow-up.
Detailed Description
BACKGROUND AND RATIONALE Septic Encephalopathy is a serious complication of sepsis / septic shock. In postmortem, human brain samples, two forms of neuraxonal injury have been described, namely, scattered ischemic lesions and diffuse injury. Prior evidence suggests that cerebral autoregulation is impaired in patients with septic shock, and this may render the central nervous system more vulnerable to direct ischemic damage, especially during episodes of hypotension. Near-infrared spectroscopy (NIRS) constitutes an established method of noninvasive assessment of cerebral autoregulation and provides the capability of semiquantitative assessment of regional cerebral blood flow. In the context of a multicenter randomized clinical trial (RCT) evaluating the effect of steroids and antioxidants on the outcome of septic shock, we aim to assess cerebral autoregulation and frontal cortex perfusion using NIRS in patients who will be enrolled in the 25-bed intensive care unit (ICU) of Evaggelismos Hospital, Athens, Greece. The rationale of the main study is based on the following facts: A large body of experimental data has demonstrated that both corticosteroids and intravenous vitamin C reduce activation of nuclear factor kappa beta (NFƘB), thereby attenuating the release of pro-inflammatory mediators. This may result in reduced endothelial permeability and improved macrocirculatory flow, and augmentation of the release of endogenous catecholamines and enhanced vasopressor responsiveness. Furthermore, a combined attenuation of the systemic inflammatory response, reduced vascular leakage, and improved macrocirculatory flow may partly contribute to the preservation of cerebral autoregulation and effective, regional brain perfusion. In addition, recent evidence suggests that thiamine may be neuroprotective in severe shock states. Regarding the rationale and hypotheses of the current substudy: Recent, observational data suggest that impaired cerebral autoregulation is independently associated with 3-month mortality in patients with septic shock. Therefore, the current project aims to test the following hypotheses: 1) The steroids/vitamin C/thiamine intervention may result in attenuation of the septic shock-associated impairment in cerebral autoregulation; and 2) The increased frequency of intact cerebral autoregulation in the intervention group may result in more neurologic failure free days and ventilator free days during a 60-day follow-up; improved survival to hospital discharge with good functional outcome; and better patient-reported health-related outcomes at 90-day follow-up. METHODS NIRS monitoring will be applied for 60 min at 2 levels of mean arterial pressure (MAP; ie, 65-70 mmHg and 95-100 mmHg) within 24-30 hours, and within 48-54 hours and 72-78 hours after the diagnosis of the septic shock. Autoregulation will be assessed by using tissue oxygenation index values and concurrently recorded MAP values in a regression analysis and will be considered as adequate if the pertinent Pearson correlation coefficient is lower than 0.3. Cerebral blood flow will be assessed by determination of the blood flow index after bolus injection of 5 mg of indocyanine green. Patients will be randomized to the intervention or control group in subgroups of 4 using the "Research Randomizer" software, version 4 (https://www.randomizer.org/). Substudy intervention: In concordance with the main study protocol as approved by the Institutional Review Board (IRB; ie, the Scientific Council) of Evaggelismos Hospital, Athens Greece, the substudy intervention will comprise the following: Hydrocortisone: Hydrocortisone 50 mg initial/single bolus (5-mL syringe containing 50 mg of hydrocortisone in normal saline), followed by a 24-hour continuous infusion of 200 mg/day for 4 days. The daily hydrocortisone dose of 200 mg will be diluted in a 50 or 100 mL bag of normal saline. Hydrocortisone placebo will be provided as an identical syringe/50 or 100 mL bag of normal saline. Vitamin C: Vitamin C is provided by the manufacturer as a 50 mL vial at a concentration of 500mg/mL. Three (3) ml of the vitamin C solution will be diluted in a 50 or 100 mL bag of normal saline (1500 mg vitamin C in a 50 mL bag) which will then be infused over 1 hour. The bag will be labeled by the study's pharmacy team as "vitamin C". The dosing schedule is 1500 mg every 6 hours for 4 days or until discharge from the ICU. Vitamin C placebo will consist of an identical bag of 50 or 100 mL normal saline (but with no vitamin C) and will be labeled vitamin C. Placebo will be infused over 60 min as per the infusion instructions of the active vitamin. Thiamine: As a high percentage of septic patients have been shown to be thiamine-deficient, patients will receive intravenous thiamine 200 mg every 12 hours for 4 days or until ICU discharge. Thiamine is also a cofactor for the metabolism of oxalate (a byproduct of vitamin C metabolism), with thiamine deficiency increasing oxalate levels. To simplify the study protocol both the intervention and the control group will receive thiamine. The study inclusion and exclusion criteria are detailed in the dedicated subsections. DOCUMENTATION AND PATIENT FOLLOW-UP Monitoring of patients over the first 10 days after randomization will include: 1) Determination and recording of hemodynamic parameters and hemodynamic support, blood gases and fluid balance over the previous 24 hours as well as arterial blood lactate and central venous oxygen saturation; 2) Blood sampling at 24, 48 and 72 hours and 7 days after randomization for determination of cytokines' concentrations; 3) Daily, routine laboratory investigations' results and prescribed treatment data; 4) the results of 4 daily (1 / 6 hours) blood glucose measurements will be recorded and the incidence of hyperglycemia (defined as blood glucose over 200 mg/dL) will be analyzed; 5) Daily calculation of the Sequential Organ Dysfunction Assessment Score; and 6) The source of the infection, the results of blood cultures and other biological specimen cultures, and the antibiograms. The time to first cessation of vasopressor support will also be documented. Follow-up until day 60 postresuscitation will include organ failure-free days and ventilator-free days. Finally, the ICU length of stay, the hospital discharge date, and the morbidity and complications / adverse events during hospital stay will be recorded. ICU management protocol: All septic patients enrolled in this study will be managed by a standardized approach which will comprise: Empirical treatment with at least 2 broad spectrum antibiotics; antibiotic treatment will be deescalated according to microbiological data and clinical improvement A conservative strategy of fluid management A lung-protective ventilation strategy Limited use of sedative agents according to pertinent guidelines Enteral nutrition which will be started at 24 hours after ICU admission Prophylaxis against deep venous thrombosis prophylaxis with both enoxaparin (or heparin in patients with a calculated creatinine clearance < 30 mL/min) and sequential compression/decompression stockings Permissive hyperglycemia (ie, blood glucose of 150-200 mg/dL) The study outcome measures are detailed in the dedicated subsection. Sample size calculation: The previously reported frequency of impaired cerebral autoregulation is approximately 60% on day 2 after the diagnosis of sepsis/septic shock (3). The detection of a study intervention-related halving of the aforementioned proportion with an alpha value of 0.05 and a power of 0,80 would require the enrollment of 96 patients. As we estimate that at least 100 patients will be enrolled at Evagglismos hospital in the context of the steroids - vitamin C - thiamine multicenter RCT, we also propose a target enrollment of 100 patients for the current substudy. G Power 3.1.9.2 Exact - Proportions: Inequality, two independent groups (Fisher's exact test) Options: Exact distribution Analysis: A priori: Compute required sample size Input: Tail(s) = Two Proportion p1 = 0.30 Proportion p2 = 0.60 α err prob = 0.05 Power (1-β err prob) = 0.80 Allocation ratio N2/N1 = 1 Output: Sample size group 1 = 48 Sample size group 2 = 48 Total sample size = 96 Actual power = 0.8004595 Actual α = 0.0290919 POSSIBLE SIGNIFICANCE OF STUDY RESULTS: In view of encouraging preliminary data on the corticosteroids / vitamin C, thiamine combination, we expect that the results of the current study will further elucidate important mechanisms underlying the (speculated) intervention-related benefit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Shock, Septic, Cerebrovascular Circulation, Spectroscopy, Near-Infrared, Patient Reported Outcome Measure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, randomized, doubleblind, placebo-controlled, parallel-group clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participant, Care Provider, Investigator, Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steroids/Vitamin C group
Arm Type
Experimental
Arm Description
"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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
"Placebo plus placebo:" Patients with septic shock treated with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone) for 4 days after randomization.
Intervention Type
Drug
Intervention Name(s)
Stress-dose Hydrocortisone plus Vitamin C
Other Intervention Name(s)
Vitamin-Steroid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
isotonic sodium chloride solution placebo plus isotonic sodium chloride solution placebo
Other Intervention Name(s)
Placebo-placebo
Intervention Description
Treatment of septic shock with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone).
Primary Outcome Measure Information:
Title
Cerebral autoregulation
Description
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.
Time Frame
24-78 hours after randomization
Title
Cerebral blood flow
Description
Cerebral blood flow at an MAP of 65-75 mmHg and an MAP of 90-100 mmHg
Time Frame
24-78 hours after randomization
Secondary Outcome Measure Information:
Title
Neurologic failure free days
Description
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.
Time Frame
Days 1-60 after randomization
Title
Ventilator-free days
Description
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.
Time Frame
Days 1-60 after randomization
Title
Favorable, Inhospital, Neurological Outcome
Description
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.
Time Frame
Days 1-60 after randomization
Title
Patient-reported health-related quality of life: SF-36
Description
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.
Time Frame
90 days after randomization
Title
Biomarkers
Description
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.
Time Frame
24-72 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Diagnosis of septic shock within 12 hours of admission to the intensive care unit (ICU). Exclusion Criteria: Age < 18 years Pregnancy Patients with a fatal underlying disease who are unlikely to survive to hospital discharge Patients with acquired immunodeficiency and a CD4 count of < 50 / μL Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency. Patients with sepsis/septic shock transferred from another hospital Patients with features of sepsis/septic shock > 12 hours Patients who require treatment with corticosteroids for an indication other than sepsis Patients with any history of an allergic reaction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Spyros D Mentzelopoulos, MD, PhD
Phone
+306975304909
Email
sdmentzelopoulos@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Spyros G Zakynthinos, MD, PhD
Phone
+306977673885
Email
szakynthinos@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spyros D Mentzelopoulos, MD, PhD
Organizational Affiliation
University of Athens Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anastasia Kotanidou, MD, PhD
Organizational Affiliation
University of Athens Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stylianos Orfanos, MD, PhD
Organizational Affiliation
University of Athens Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Spyros G Zakynthinos, MD. PhD
Organizational Affiliation
University of Athens Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Evaggelismos General Hospital
City
Athens
State/Province
Attica
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spyros D Mentzelopoulos, MD, PhD
Phone
+306975304909
Email
sdmentzelopoulos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Spyros D Mentzelopoulos, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anastasia Kotanidou, MD, PhD
First Name & Middle Initial & Last Name & Degree
George Bouboulis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sotirios Malachias, MD, PhD
First Name & Middle Initial & Last Name & Degree
Edison Jahaj, MD
First Name & Middle Initial & Last Name & Degree
Elpida Charalampaki, MD
First Name & Middle Initial & Last Name & Degree
Evanthia Pappa, MD
First Name & Middle Initial & Last Name & Degree
Marios Kougias, MD
First Name & Middle Initial & Last Name & Degree
Zafeiris Louvaris, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No specific plan
Citations:
PubMed Identifier
29058589
Citation
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Results Reference
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19806473
Citation
Taccone FS, Castanares-Zapatero D, Peres-Bota D, Vincent JL, Berre' J, Melot C. Cerebral autoregulation is influenced by carbon dioxide levels in patients with septic shock. Neurocrit Care. 2010 Feb;12(1):35-42. doi: 10.1007/s12028-009-9289-6.
Results Reference
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PubMed Identifier
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Citation
Schramm P, Klein KU, Falkenberg L, Berres M, Closhen D, Werhahn KJ, David M, Werner C, Engelhard K. Impaired cerebrovascular autoregulation in patients with severe sepsis and sepsis-associated delirium. Crit Care. 2012 Oct 4;16(5):R181. doi: 10.1186/cc11665.
Results Reference
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Citation
Donnelly J, Budohoski KP, Smielewski P, Czosnyka M. Regulation of the cerebral circulation: bedside assessment and clinical implications. Crit Care. 2016 May 5;20(1):129. doi: 10.1186/s13054-016-1293-6.
Results Reference
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Citation
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Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock

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