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Completed

NCT Number: NCT06152458

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

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesia and Intensive Therapy University of Pecs

Pécs, Baranya, 7624, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Drug

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

Primary outcomes

  1. ventilation

    Time frame: intensive care unit discharge (up to 90 days)

    duration of mechanical ventilation (days)

  2. vasopressors

    Time frame: intensive care unit discharge (up to 90 days)

    length of circulatory support (days)

  3. Length of stay

    Time frame: intensive care unit discharge (up to 90 days)

    length of Intensive care unit staying (days)

  4. main mortality

    Time frame: intensive care unit discharge (up to 90 days)

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

Secondary outcomes

  1. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • se-carbamide (mg/dl)

  2. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • se-creatinine (µmol/L)

  3. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • plateletes (G/L),

  4. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • procalcitonin (ng/ml),

  5. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • white blood cells (G/L)

  6. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • heat shock C-reactive protein (mg/L)

  7. secondary outcomes

    Time frame: up to 5 days after admission to intensive care

    development of inflammatory laboratory parameters:

    • se-lactate (mmol/L)

  8. antibiotics

    Time frame: intensive care unit discharge (up to 90 days)

    the length of antibiotic treatment (days)

  9. PiCCO parameters

    Time frame: up to 5 days after admission to intensive care

    changes in invasive hemodynamic parameters-PiCCO ®:

    • cardiac index (l/min/m2)

  10. PiCCO parameters

    Time frame: up to 5 days after admission to intensive care

    changes in invasive hemodynamic parameters-PiCCO ®:

    • extravascular lung water (ml/kg)

  11. PiCCO parameters

    Time frame: up to 5 days after admission to intensive care

    changes in invasive hemodynamic parameters-PiCCO ®:

    • intrathoracic body water (ml/m2)

  12. PiCCO parameters

    Time frame: 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

    Time frame: up to 60 days after admission to intensive care

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

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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