A Phase 4 interventional study of Vitamin C in Septic Shock, sponsored by University of Pecs. Completed at 1 site in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University of Pecs · Phase 4, Interventional, and Treatment
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Patients in the intervention group (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.
Drug: Vitamin C
As a control group, we selected 20 age- and sex-matched patients with septic shock who did not receive vitamin treatment.They received the standard of care for septic shock.
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.
Also known as: Thiamine
ventilation
duration of mechanical ventilation (days)
Time frame: intensive care unit discharge (up to 90 days)
vasopressors
length of circulatory support (days)
Time frame: intensive care unit discharge (up to 90 days)
Length of stay
length of Intensive care unit staying (days)
Time frame: intensive care unit discharge (up to 90 days)
main mortality
all-cause mortality (dead/survived) in the intensive care unit
Time frame: intensive care unit discharge (up to 90 days)
secondary outcomes
development of inflammatory laboratory parameters: - se-carbamide (mg/dl)
Time frame: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters: - se-creatinine (µmol/L)
Time frame: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters: - plateletes (G/L),
Time frame: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters: - procalcitonin (ng/ml),
Time frame: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters: - white blood cells (G/L)
Time frame: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters: - heat shock C-reactive protein (mg/L)
Time frame: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters: - se-lactate (mmol/L)
Time frame: up to 5 days after admission to intensive care
antibiotics
the length of antibiotic treatment (days)
Time frame: intensive care unit discharge (up to 90 days)
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®: - cardiac index (l/min/m2)
Time frame: up to 5 days after admission to intensive care
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®: - extravascular lung water (ml/kg)
Time frame: up to 5 days after admission to intensive care
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®: - intrathoracic body water (ml/m2)
Time frame: up to 5 days after admission to intensive care
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®: - myocardial contractility (dP/dTmax- (mm hg/s)
Time frame: up to 5 days after admission to intensive care
other mortality's
in-hospital, 30- and 60-day mortality (dead/survived)
Time frame: up to 60 days after admission to intensive care
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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