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

Cristina Martinez

Status and phase: Completed; Phase 3

Conditions: Septic Shock; Sepsis

Treatments: Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate; Drug: on crystalloid fluid and Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04111822

EudraCT number 2018-000196-32

Details and patient eligibility

About

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.

Full 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 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Conventional treatment of septic shock

Active Comparator group

Description:

Conventional treatment of septic shock according to current management guidelines

Treatment:

Drug: on crystalloid fluid and Tranexamic acid

Current management plus ascorbic acyd,thiamine and vitamin C

Experimental group

Description:

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

Treatment:

Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate