Clinical trial NCT06152458: Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
Official title: Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Keywords: sepsis
vitamin-c
thiamine
septic shock
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ventilation
timeFrame: intensive care unit discharge (up to 90 days)
measure: vasopressors
timeFrame: intensive care unit discharge (up to 90 days)
measure: Length of stay
timeFrame: intensive care unit discharge (up to 90 days)
measure: main mortality
timeFrame: intensive care unit discharge (up to 90 days)
Secondary outcomes:
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: secondary outcomes
timeFrame: up to 5 days after admission to intensive care
measure: antibiotics
timeFrame: intensive care unit discharge (up to 90 days)
measure: PiCCO parameters
timeFrame: up to 5 days after admission to intensive care
measure: PiCCO parameters
timeFrame: up to 5 days after admission to intensive care
measure: PiCCO parameters
timeFrame: up to 5 days after admission to intensive care
measure: PiCCO parameters
timeFrame: up to 5 days after admission to intensive care
measure: other mortality's
timeFrame: up to 60 days after admission to intensive care
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Department of Anaesthesia and Intensive Therapy University of Pecs
state: Baranya
Study officials:
References: