Vitamin C, Hydrocortisone and Thiamine for Septic Shock

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.

Conditions

• Shock, Septic

Interventions

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.

DRUG

Placebo plus placebo

Treatment of septic shock with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone).

Sponsors & Collaborators

• General Hospital of Nikaia "Saint Panteleimon"

  collaborator OTHER

• Naval Hospital, Athens

  collaborator OTHER

• University of Athens

  lead OTHER

Principal Investigators

• Anastasia Kotanidou, MD, PHD, Professor · National and Kapodestrian University of Athens, Greece

• Spyros D Mentzelopoulos, MD, PHD, Associate Professor · National and Kapodestrian University of Athens, Greece

• Stylianos Orfanos, MD, PHD, Professor · National and Kapodestrian University of Athens, Greece

• Spyros G Zakynthinos, MD, PHD, Professor · National and Kapodestrian University of Athens, Greece

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