Status:
COMPLETED
Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
Lead Sponsor:
Cristina Martinez
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 in...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04111822
Start Date
October 31 2018
End Date
October 31 2020
Last Update
October 6 2023
Active Locations (1)
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1
Hospital Dr Josep Trueta
Girona, Spain, 17007