NCT04111822

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cristina Martinez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate	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
DRUG	on crystalloid fluid and Tranexamic acid	Resuscitation with crystalloids, Performing culture battery, antibiotic therapy

Timeline

• Start date: 2018-10-31
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2019-10-01
• Last updated: 2023-10-06

Locations

1 site across 1 country: Spain