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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06152458
• Other study ID #: 7849-PTE 2019
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: November 2023
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Hungary	Department of Anaesthesia and Intensive Therapy University of Pecs	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

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