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

Phase 4

Completed

• Conditions: Septic Shock
• Interventions: Drug: Vitamin C

• Registration Number: NCT06152458
• Lead Sponsor: University of Pecs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Study First Submitted: 2023-09-01
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Vitamin C	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
secondary outcomes	up to 5 days after admission to intensive care	development of inflammatory laboratory parameters: - se-lactate (mmol/L)
antibiotics	intensive care unit discharge (up to 90 days)	the length of antibiotic treatment (days)
PiCCO parameters	up to 5 days after admission to intensive care	changes in invasive hemodynamic parameters-PiCCO ®: - myocardial contractility (dP/dTmax- (mm hg/s)
other mortality's	up to 60 days after admission to intensive care	in-hospital, 30- and 60-day mortality (dead/survived)

Trial Locations

Locations (1)

Department of Anaesthesia and Intensive Therapy University of Pecs; 🇭🇺 Pécs, Baranya, Hungary