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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Sepsis, Septic Shock

Intervention / Treatment
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* Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate
* Drug: on crystalloid fluid and Tranexamic acid


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment of septic shock<br>Conventional treatment of septic shock according to current management guidelines | Drug: on crystalloid fluid and Tranexamic acid<br>* Resuscitation with crystalloids, Performing culture battery, antibiotic therapy<br>* Other names: clinical practice intervention;|
| Experimental: Current management plus ascorbic acyd,thiamine and vitamin C<br>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 | Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate<br>* 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<br>* Other names: experimental intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | number of days that patient stay in ICU department | 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 | compare the days of use of mechanical ventilation in every arm | 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. | compare the days of need for vasoactive drug requirements in both groups | 28 days |