Back to resultsPilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
Primary Purpose
Sepsis, Septic Shock
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate
on crystalloid fluid and Tranexamic acid
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
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).
Sites / Locations
- Hospital Dr Josep Trueta
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment of septic shock
Current management plus ascorbic acyd,thiamine and vitamin C
Arm Description
Conventional treatment of septic shock according to current management guidelines
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04111822
Brief Title
Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
Official Title
Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Martinez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment of septic shock
Arm Type
Active Comparator
Arm Description
Conventional treatment of septic shock according to current management guidelines
Arm Title
Current management plus ascorbic acyd,thiamine and vitamin C
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate
Other Intervention Name(s)
experimental intervention
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
on crystalloid fluid and Tranexamic acid
Other Intervention Name(s)
clinical practice intervention
Intervention Description
Resuscitation with crystalloids, Performing culture battery, antibiotic therapy
Primary Outcome Measure Information:
Title
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
Description
Number of patients that are alive after 28 days of admission
Time Frame
28 days
Title
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.
Description
Number of patients that are exitus at 7, 14 and 28 days after admission
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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.
Description
number of days that patient stay in ICU department
Time Frame
28 days
Title
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
Description
compare the days of use of mechanical ventilation in every arm
Time Frame
28 days
Title
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.
Description
compare the days of need for vasoactive drug requirements in both groups
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Gonzalez, MD
Organizational Affiliation
Hospital Dr Josep Trueta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
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