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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03335124
• Date of registration: 25/10/2017
• Prospective Registration: No
• Primary sponsor: University Medical Centre Ljubljana
• Public title: The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
• Scientific title: A Randomized, Double Blind, Placebo-Controlled Study to Investigate the Effects of Vitamin C, Hydrocortisone and Thiamine on the Outcome of Patients With Severe Sepsis and Septic Shock
• Date of first enrolment: September 26, 2017
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03335124
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

Slovenia

Contacts

• Name: Sebastian Stefanovic, MD
• Affiliation: University Medical Center Ljubljana, Department of Gastroenterology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of severe sepsis or septic shock within 12 hours of admission in our
Intensive Care Unit (ICU).

- Informed consent.

Exclusion Criteria:

- Age < 18 years

- Pregnancy

- Do Not Resuscitate (DNR/DNI) with limitations of care

- Patients with fatal underlying disease who are unlikely to survive to hospital
discharge (e.g.: disseminated malignant disease)

- Patients primarily admitted for acute coronary syndromes, acute cerebrovascular
incidents or active gastrointestinal (GI) bleeds

- Patients that need immediate surgical treatment

- Patients with HIV and a cell count of cluster of differentiation 4 (CD4) cells < 50
mm2,

- Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.

- Patients with severe sepsis/septic shock transferred from another hospital

- Patients with features of sepsis/septic shock > 24 hours

- Patients who require treatment with corticosteroids for an indication other than
sepsis (chronic corticosteroid use, known Addison's Disease, Ulcerative colitis,
Crohn's disease...)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Septic Shock

Fluid Overload

Sepsis

Critical Illness

Intervention(s)

Drug: Thiamine

Drug: 0.9% Sodium Chloride Injection

Drug: Hydrocortisone

Drug: Vitamin C

Primary Outcome(s)

Hospital mortality [Time Frame: From date of randomization till time of discharge, assessed up to 12 months]

Secondary Outcome(s)

ICU length of stay (LOS) and ICU free days. [Time Frame: ICU free days is calculated as the number of days alive and out of the ICU to day 28]

60 day mortality [Time Frame: 60 days from inclusion in the study]

Delta SOFA score [Time Frame: The first 4 days in Intensive Care Unit]

Hospital Length of Stay [Time Frame: Hospital Length of Stay through the study completion, assessed up to 12 months]

Time to vasopressor independence [Time Frame: Defined as the time from starting the active treatment/placebo to discontinuation of all pressors, till discharged from ICU, assessed in the first month]

PCT clearance [Time Frame: The first 4 days in Intensive Care Unit]

28 day mortality [Time Frame: 28 days from inclusion in the study]

Secondary ID(s)

CSEPSIS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors