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

NCT06152458 | Completed Phase 4

• 1 other identifier: 7849-PTE 2019
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

sepsis; vitamin-c; thiamine; septic shock

Outcome Measures

Primary Outcomes (4)

• ventilation

  duration of mechanical ventilation (days)

  intensive care unit discharge (up to 90 days)

• vasopressors

  length of circulatory support (days)

  intensive care unit discharge (up to 90 days)

• Length of stay

  length of Intensive care unit staying (days)

  intensive care unit discharge (up to 90 days)

• main mortality

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

  intensive care unit discharge (up to 90 days)

Secondary Outcomes (13)

• secondary outcomes

  up to 5 days after admission to intensive care

• secondary outcomes

  up to 5 days after admission to intensive care

• secondary outcomes

  up to 5 days after admission to intensive care

• secondary outcomes

  up to 5 days after admission to intensive care

• secondary outcomes

  up to 5 days after admission to intensive care

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Thiamine

intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• septic shock
• intensive care unit administration

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Department of Anaesthesia and Intensive Therapy University of Pecs

Pécs, Baranya, 7624, Hungary

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Ascorbic Acid; Thiamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

HU (1)