Status:
TERMINATED
Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock
Lead Sponsor:
Hospital Sirio-Libanes
Collaborating Sponsors:
PROADI-SUS
Ministry of Health, Brazil
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A great interest exists regarding substances with an immunomodulatory effect for sepsis patients. Recent data have shown that intravenous vitamin C, together with corticosteroids and thiamine, could p...
Detailed Description
The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year, most occurring in low-income countries. With recent advances in diagnosis and supportive treatment, the 28...
Eligibility Criteria
Inclusion
- Above 18 years of age
- Sepsis of any background
- Vasopressor-dependent sepsis for at least 2 hours and vasopressor dose ≥ 0.25 µg / kg / min
Exclusion
- Pregnancy;
- Requests for DNR (do not resuscitate) / DNI (do not intubate);
- Death is considered imminent or inevitable during this hospitalization and the attending physician, patient or substitute decision maker is not committed to active treatment;
- Patients with acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma at admission;
- Patients with known HIV infection;
- Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
- Patients with septic shock transferred from another ICU or hospital with characteristics of septic shock for\> 12 hours;
- Patients with septic shock characteristics for\> 12 hours;
- Patients with a known history of oxalate nephropathy;
- Patients with short bowel syndrome or severe known fat malabsorption;
- Patients with acute beriberi disease;
- Patients with acute Wernicke's encephalopathy;
- Patients with known malaria;
- Patients with known or suspected scurvy;
- Patients with known or suspected Addison's disease;
- Patients with known Cushing's disease;
- Physician expects to prescribe or the patient has previously used (less than 15 days) systemic glucocorticoids for an indication other than septic shock (not including nebulized or inhaled corticosteroids), including the use of glucocorticoids for COVID-19;
- The patient is receiving treatment for systemic fungal infection or has documented Strongyloides infection at the time of randomization;
- Patient with known chronic iron overload due to iron storage and other diseases;
- Patient previously enrolled in this study.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05192213
Start Date
August 1 2021
End Date
September 19 2022
Last Update
January 30 2024
Active Locations (12)
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1
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
2
Hospital Otoclinica
Fortaleza, Ceará, Brazil, 60135-100
3
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, Brazil
4
Hospital Clínica São Roque
Ipiaú, Estado de Bahia, Brazil