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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111822
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cristina Martinez, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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.

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Drug: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate Drug: on crystalloid fluid and Tranexamic acid Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional treatment of septic shock
Conventional treatment of septic shock according to current management guidelines
Drug: on crystalloid fluid and Tranexamic acid
Resuscitation with crystalloids, Performing culture battery, antibiotic therapy
Other Name: clinical practice intervention

Experimental: Current management plus ascorbic acyd,thiamine and vitamin C

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

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
Other Name: experimental intervention




Primary Outcome Measures :
  1. 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 [ Time Frame: 28 days ]
    Number of patients that are alive after 28 days of admission

  2. 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. [ Time Frame: 28 days ]
    Number of patients that are exitus at 7, 14 and 28 days after admission


Secondary Outcome Measures :
  1. 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. [ Time Frame: 28 days ]
    number of days that patient stay in ICU department

  2. 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 [ Time Frame: 28 days ]
    compare the days of use of mechanical ventilation in every arm

  3. 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. [ Time Frame: 28 days ]
    compare the days of need for vasoactive drug requirements in both groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111822


Contacts
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Contact: Cristina Martinez, MSc 972940200 ext 2343 cmartinez@idibgi.-org

Locations
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Spain
Hospital Dr Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Cristina Martinez, MSc    972940200 ext 2343    cmartinez@idibgi.org   
Principal Investigator: Juliana Gonzalez, MD         
Sub-Investigator: Josep Maria Sirvent, MD         
Sub-Investigator: Liliana Vera Ching, MD         
Sub-Investigator: Patricia Sebastian Cernuda, MD         
Sub-Investigator: Mireia Vila, Pharmacist         
Sponsors and Collaborators
Cristina Martinez
Investigators
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Principal Investigator: Juliana Gonzalez, MD Hospital Dr Josep Trueta
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Responsible Party: Cristina Martinez, Master in Science and clinical reseracher manager, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT04111822    
Other Study ID Numbers: EudraCT number 2018-000196-32
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants