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

Sponsor
University of Pecs (Other)
Overall Status
Completed
CT.gov ID
NCT06152458
Collaborator
(none)
43
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin C
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

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
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.
Other Names:
  • Thiamine

    		•
    No Intervention: control group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. ventilation [intensive care unit discharge (up to 90 days)]

      duration of mechanical ventilation (days)

    2. vasopressors [intensive care unit discharge (up to 90 days)]

      length of circulatory support (days)

    3. Length of stay [intensive care unit discharge (up to 90 days)]

      length of Intensive care unit staying (days)

    4. main mortality [intensive care unit discharge (up to 90 days)]

      all-cause mortality (dead/survived) in the intensive care unit

    Secondary Outcome Measures

    1. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - se-carbamide (mg/dl)

    2. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - se-creatinine (µmol/L)

    3. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - plateletes (G/L),

    4. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - procalcitonin (ng/ml),

    5. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - white blood cells (G/L)

    6. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - heat shock C-reactive protein (mg/L)

    7. secondary outcomes [up to 5 days after admission to intensive care]

      development of inflammatory laboratory parameters: - se-lactate (mmol/L)

    8. antibiotics [intensive care unit discharge (up to 90 days)]

      the length of antibiotic treatment (days)

    9. PiCCO parameters [up to 5 days after admission to intensive care]

      changes in invasive hemodynamic parameters-PiCCO ®: - cardiac index (l/min/m2)

    10. PiCCO parameters [up to 5 days after admission to intensive care]

      changes in invasive hemodynamic parameters-PiCCO ®: - extravascular lung water (ml/kg)

    11. PiCCO parameters [up to 5 days after admission to intensive care]

      changes in invasive hemodynamic parameters-PiCCO ®: - intrathoracic body water (ml/m2)

    12. PiCCO parameters [up to 5 days after admission to intensive care]

      changes in invasive hemodynamic parameters-PiCCO ®: - myocardial contractility (dP/dTmax- (mm hg/s)

    13. other mortality's [up to 60 days after admission to intensive care]

      in-hospital, 30- and 60-day mortality (dead/survived)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesia and Intensive Therapy University of Pecs Pécs Baranya Hungary 7624

    Sponsors and Collaborators

    • University of Pecs

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pecs
    ClinicalTrials.gov Identifier:
    NCT06152458
    Other Study ID Numbers:
    • 7849-PTE 2019
    First Posted:
    Nov 30, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Pecs
    sepsis
    vitamin-c
    thiamine
    septic shock
    Additional relevant MeSH terms:
    Shock, Septic
    Shock
    Thiamine

    Study Results

    No Results Posted as of Nov 30, 2023