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

Study Overview
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Brief Summary
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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.

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Vitamin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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<br>* 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.<br>* Other names: Thiamine;|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation | duration of mechanical ventilation (days) | intensive care unit discharge (up to 90 days) | 
| vasopressors | length of circulatory support (days) | intensive care unit discharge (up to 90 days) | 
| Length of stay | length of Intensive care unit staying (days) | intensive care unit discharge (up to 90 days) | 
| main mortality | all-cause mortality (dead/survived) in the intensive care unit | intensive care unit discharge (up to 90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary outcomes | development of inflammatory laboratory parameters: - se-carbamide (mg/dl) | up to 5 days after admission to intensive care | 
| secondary outcomes | development of inflammatory laboratory parameters: - se-creatinine (µmol/L) | up to 5 days after admission to intensive care | 
| secondary outcomes | development of inflammatory laboratory parameters: - plateletes (G/L), | up to 5 days after admission to intensive care | 
| secondary outcomes | development of inflammatory laboratory parameters: - procalcitonin (ng/ml), | up to 5 days after admission to intensive care | 
| secondary outcomes | development of inflammatory laboratory parameters: - white blood cells (G/L) | up to 5 days after admission to intensive care | 
| secondary outcomes | development of inflammatory laboratory parameters: - heat shock C-reactive protein (mg/L) | up to 5 days after admission to intensive care | 
| secondary outcomes | development of inflammatory laboratory parameters: - se-lactate (mmol/L) | up to 5 days after admission to intensive care | 
| antibiotics | the length of antibiotic treatment (days) | intensive care unit discharge (up to 90 days) | 
| PiCCO parameters | changes in invasive hemodynamic parameters-PiCCO ®: - cardiac index (l/min/m2) | up to 5 days after admission to intensive care | 
| PiCCO parameters | changes in invasive hemodynamic parameters-PiCCO ®: - extravascular lung water (ml/kg) | up to 5 days after admission to intensive care | 
| PiCCO parameters | changes in invasive hemodynamic parameters-PiCCO ®: - intrathoracic body water (ml/m2) | up to 5 days after admission to intensive care | 
| PiCCO parameters | changes in invasive hemodynamic parameters-PiCCO ®: - myocardial contractility (dP/dTmax- (mm hg/s) | up to 5 days after admission to intensive care | 
| other mortality's | in-hospital, 30- and 60-day mortality (dead/survived) | up to 60 days after admission to intensive care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, vitamin-c, thiamine, septic shock