EFFECTS OF HYDROCORTISONE, VITAMIN C AND THYAMINE IN PATIENTS WITH GENERALIZED INFECTIO

Phase 1

• Conditions: sepsis and septic shock; MedDRA version: 20.0Level: HLTClassification code 10040054Term: Sepsis, bacteraemia, viraemia and fungaemia NECSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-000196-32-ES
• Lead Sponsor: HU DE GIRONA DR JOSEP TRUETA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-01
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

* Patients> 18 years of age with diagnosis of septic shock and multiple organ failure admitted to our Unit
* Admission in ICU once diagnosed of sepsis and / or septic shock. The first 24 hours after admission to the ICU will be established as the inclusion limit.
* Signed Informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

* Patients under 18 years of age
* Pregnancy
* Coexistence of other types of shock at the time of admission
* Limitation of therapeutic effort or ICT (Conditioned Intensive Therapy) to admission to the ICU. It refers to patients in whom prior to admission to the ICU it has been decided not to perform any or some of the usual treatment measures of 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 doctor and if it exists, the patient would be excluded from the study.
* Patient with a history of previous intake of ascorbic acid, thiamin 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified