Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock

Due to the high incidence, mortality and short and long term complications of sepsis and septic shock, it is necessary to look for strategies to try to minimize this impact.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock
• Intervention / Treatment: Drug: on crystalloid fluid and Tranexamic acid; Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate

Detailed Description

Based on the current literature, we can affirm that the decrease in ascorbic acid levels in patients with sepsis and septic shock is directly proportional to the evolution to multiorgan failure and inversely proportional to survival. After assessing the safety in the administration of ascorbic acid as well as the decrease or almost abolition of its impact at the renal level after the association of thiamine, and the synergy provided by the administration of hydrocortisone, it is decided to implement the "Metabolic Resucitation Protocol" and assess its impact on our septic patients

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain, 17007
    • Hospital Dr Josep Trueta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients> 18 years of age with diagnosis of septic shock and multiorgan failure admitted to our Unit
• Entry into the ICU once diagnosed with sepsis and / or septic shock. The first 24 hours after admission to the ICU will be established as an inclusion limit
• Written informed consent.

Exclusion Criteria:

• Patients under 18
• Pregnancy
• Coexistence of other types of shock at admission
• Limitation of therapeutic effort or ICT (Conditional Intensive Therapy) upon admission to the ICU. It refers to patients in whom, prior to admission to the ICU, it was decided not to perform any or some of the usual treatment measures for sepsis, or in which a time limit is established in which in case of non-response they would withdraw intensive measures. This limitation will be indicated by your treating physician and if it exists, the patient would be excluded from the study.
• Patient with a history of previous intake of ascorbic acid, thiamine or corticosteroids in the month prior to admission to the ICU
• Patients considered immunodeficient (More than 10 mg of prednisone or its equivalent per day in the last 2 weeks, immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment of septic shock; Conventional treatment of septic shock according to current management guidelines	Drug: on crystalloid fluid and Tranexamic acid; Resuscitation with crystalloids, Performing culture battery, antibiotic therapy; Other Names: clinical practice intervention
Experimental: Current management plus ascorbic acyd,thiamine and vitamin C; Conventional treatment of septic shock according to current management guidelines associated with: i. Hydrocortisone 50 mg every 6 hours for 7 days or until discharge from the ICU with subsequent withdrawal in descending pattern for 3 days ii. Vitamin C (ascorbic acid) 1.5 gr diluted in 100 ml of 5% SG every 6 hours for 4 days (16 doses) iii. Thiamine 200 mg diluted in 100 ml of SG 5% or SF 0.9% every 12 hours for 4 days iv. Measurement of vitamin C levels prior to administration of the first dose of vitamin C	Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate; Phase III, randomized, multicenter, open-label and parallel group pilot study, which aims to study mortality at 28 days of admission in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual driving; Other Names: experimental intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate and compare hospital survival after 28 days of admission in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual management	Number of patients that are alive after 28 days of admission	28 days
Compare mortality at 7, 14 and 28 days after admission in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual management.	Number of patients that are exitus at 7, 14 and 28 days after admission	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the days of admission to the ICU in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual management.	number of days that patient stay in ICU department	28 days
Compare the days of mechanical ventilation in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual management	compare the days of use of mechanical ventilation in every arm	28 days
Compare the days of need for vasoactive drug requirements and doses in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual management.	compare the days of need for vasoactive drug requirements in both groups	28 days

Collaborators and Investigators

• Sponsor: Cristina Martinez
• Investigators: Principal Investigator: Juliana Gonzalez, MD, Hospital Dr Josep Trueta

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: EudraCT number 2018-000196-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No