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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment of septic shock | Active Comparator | Conventional treatment of septic shock according to current management guidelines |
|
| Current management plus ascorbic acyd,thiamine and vitamin C | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliana Gonzalez, MD | Hospital Dr Josep Trueta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dr Josep Trueta | Girona | 17007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37985341 | Derived | 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. |
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|
|
| on crystalloid fluid and Tranexamic acid | Drug | Resuscitation with crystalloids, Performing culture battery, antibiotic therapy |
|
|
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 |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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