Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 sepsis
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2018
CompletedFirst Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedOctober 6, 2023
October 1, 2023
2 years
August 5, 2019
October 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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.
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
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.
28 days
Study Arms (2)
Conventional treatment of septic shock
ACTIVE COMPARATORConventional treatment of septic shock according to current management guidelines
Current management plus ascorbic acyd,thiamine and vitamin C
EXPERIMENTALConventional 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
Interventions
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
Resuscitation with crystalloids, Performing culture battery, antibiotic therapy
Eligibility Criteria
You may qualify if:
- Patients\> 18 years of age with diagnosis of septic shock and multiorgan failure admitted to our Unit
- Written informed consent.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Dr Josep Trueta
Girona, 17007, Spain
Related Publications (1)
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.
PMID: 37985341DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliana Gonzalez, MD
Hospital Dr Josep Trueta
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Master in Science and clinical reseracher manager
Study Record Dates
First Submitted
August 5, 2019
First Posted
October 1, 2019
Study Start
October 31, 2018
Primary Completion
October 31, 2020
Study Completion
October 31, 2020
Last Updated
October 6, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share