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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111822
• Other study ID #: EudraCT number 2018-000196-32
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2023
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

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
• on crystalloid fluid and Tranexamic acid
Resuscitation with crystalloids, Performing culture battery, antibiotic therapy

Locations

Country	Name	City	State
Spain	Hospital Dr Josep Trueta	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Martinez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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