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Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock

NCT03649633 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-12-19

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

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.

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).

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D Mentzelopoulos, MD, PhD · University of Athens Medical School

  • Anastasia Kotanidou, MD, PhD · University of Athens Medical School

  • Stylianos Orfanos, MD, PhD · University of Athens Medical School

  • Spyros G Zakynthinos, MD. PhD · University of Athens Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-06
Primary Completion
2023-01-16
Completion
2023-01-16

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649633 on ClinicalTrials.gov