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Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.

Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06152458
Enrollment
43
Registered
2023-11-30
Start date
2019-01-01
Completion date
2020-03-01
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

sepsis, vitamin-c, thiamine, septic shock

Brief summary

Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction. Aim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients. Material and methods: In our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical analysis. Ethical license: 7849-PTE 2019.

Interventions

DRUGVitamin C

Patients in the intervention group (G1) (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.

Sponsors

University of Pecs
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* septic shock * intensive care unit administration

Exclusion criteria

* under age 18 * above age 80 * moribund patients * pregnant patients * active kidney stone * inability to obtain consent * viral or mixed sepsis * missed dose of vitamin C/ thiamin or hydrocortisone * Physician refused * Vitamin C / Thiamine/ Hydrocortisone for other indications

Design outcomes

Primary

MeasureTime frameDescription
main mortalityintensive care unit discharge (up to 90 days)all-cause mortality (dead/survived) in the intensive care unit
ventilationintensive care unit discharge (up to 90 days)duration of mechanical ventilation (days)
vasopressorsintensive care unit discharge (up to 90 days)length of circulatory support (days)
Length of stayintensive care unit discharge (up to 90 days)length of Intensive care unit staying (days)

Secondary

MeasureTime frameDescription
secondary outcomesup to 5 days after admission to intensive caredevelopment of inflammatory laboratory parameters: \- se-carbamide (mg/dl)
antibioticsintensive care unit discharge (up to 90 days)the length of antibiotic treatment (days)
PiCCO parametersup to 5 days after admission to intensive carechanges in invasive hemodynamic parameters-PiCCO ®: \- cardiac index (l/min/m2)
other mortality'sup to 60 days after admission to intensive carein-hospital, 30- and 60-day mortality (dead/survived)

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026