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The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

NCT03335124 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-02-19

No results posted yet for this study

Summary

The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.

Conditions

  • Sepsis
  • Septic Shock
  • Critical Illness
  • Fluid Overload

Interventions

DRUG

Vitamin C

Vitamin C: Vitamin C will be applied as per instructions described in arm/group descriptions.

DRUG

Hydrocortisone

Hydrocortisone: Hydrocortisone will be applied as per instructions described in arm/group descriptions.

DRUG

Thiamine

Intravenous thiamine will be applied as per instructions described in arm/group descriptions.

DRUG

0.9% Sodium Chloride Injection

0.9 % Sodium Chloride will be applied as placebo as per instructions described in arm/group descriptions.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Sebastian Stefanovic, MD · University Medical Center Ljubljana, Department of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • Slovenia

Study Locations

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Entities

Diseases

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 NCT03335124 on ClinicalTrials.gov