Clinical trial

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

Name

7849-PTE 2019

Description

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.

Trial arms

Trial start

2019-01-01

Estimated PCD

2020-03-01

Trial end

2020-03-01

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

intervention group

Other names:

Thiamine

Size

Primary endpoint

ventilation

intensive care unit discharge (up to 90 days)

vasopressors

intensive care unit discharge (up to 90 days)

Length of stay

intensive care unit discharge (up to 90 days)

main mortality

intensive care unit discharge (up to 90 days)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

Updated at

2023-11-30

1 organization

1 product

1 indication

Organization

University of Pecs

Product

Vitamin C

Indication

Septic shock