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

NCT ID: NCT04111822

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-10-31

Brief Summary

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.

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

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional treatment of septic shock

Conventional treatment of septic shock according to current management guidelines

Group Type: ACTIVE_COMPARATOR

on crystalloid fluid and Tranexamic acid

Intervention Type: DRUG

Resuscitation with crystalloids, Performing culture battery, antibiotic therapy

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

Group Type: EXPERIMENTAL

red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

on crystalloid fluid and Tranexamic acid

Resuscitation with crystalloids, Performing culture battery, antibiotic therapy

Intervention Type: DRUG

Other Intervention Names

experimental intervention; clinical practice intervention

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cristina Martinez

OTHER

Sponsor Role: lead

Responsible Party

Cristina Martinez

Master in Science and clinical reseracher manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juliana Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr Josep Trueta

Locations

Hospital Dr Josep Trueta

Girona, , Spain

Countries

Spain

References

Gonzalez Londono J, Vera Ching C, Sebastian Cernuda P, Morales Pedrosa JM, Lorencio C, Sirvent JM. Effect of vitamin C, thiamine and hydrocortisone in critically ill septic patients. The Metabolic Resus RCT. Med Intensiva (Engl Ed). 2024 Apr;48(4):238-240. doi: 10.1016/j.medine.2023.11.002. Epub 2023 Nov 18. No abstract available.

Reference Type: DERIVED

PMID: 37985341 (View on PubMed)

Other Identifiers

EudraCT number 2018-000196-32

Identifier Type: -

Identifier Source: org_study_id