sepsis and septic shock MedDRA version: 20.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Hidrocortisone
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE
CAS Number: 6000-74-4
Current Sponsor code: ACTOCORTINA
Conce
Sponsors
HU DE GIRONA DR JOSEP TRUETA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: * Estimate and compare the hospital survival at 28 days of admission in patients with septic shock treated with the usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to the usual management * Compare the mortality at 7, 14 and 28 days of admission in patients with septic shock treated with the usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to the usual management;Secondary Objective: * Compare the days of admission to the ICU in patients with septic shock treated with the usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to the usual management. * Compare the days of mechanical ventilation in patients with septic shock treated with the usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to the usual management. * Compare the days of need for vasoactive drug requirements and doses in patients with septic shock treated with the usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to the usual management;Primary end point(s): Mortality 28 days after admission to the ICU.;Timepoint(s) of evaluation of this end point: 28 days after admission | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Admission days in ICU: Number of days the patient has been admitted to the ICU due to sepsis • Days of mechanical ventilation: Number of days the patient has required mechanical ventilation • Days of vasoactive drugs: Number of days the patient required vasoactive drugs • Maximum dose of vasoactive drugs per day: Maximum dose of vasoactive drugs daily during the first 7 days of treatment;Timepoint(s) of evaluation of this end point: Discharge date or exitus | — |
Countries
Spain
Contacts
Public ContactCRISTINA MARTINEZ
HU DE GIRONA DR JOSEP TRUETA
Outcome results
None listed