Status:
TERMINATED
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are d...
Detailed Description
AIM OF THE STUDY: The goal is to determine the effects on clinical course and outcome of patients with severe sepsis and septic shock treated with vitamin C, hydrocortisone and thiamine. BACKGROUND:...
Eligibility Criteria
Inclusion
- Diagnosis of severe sepsis or septic shock within 12 hours of admission in our Intensive Care Unit (ICU).
- Informed consent.
Exclusion
- Age \< 18 years
- Pregnancy
- Do Not Resuscitate (DNR/DNI) with limitations of care
- Patients with fatal underlying disease who are unlikely to survive to hospital discharge (e.g.: disseminated malignant disease)
- Patients primarily admitted for acute coronary syndromes, acute cerebrovascular incidents or active gastrointestinal (GI) bleeds
- Patients that need immediate surgical treatment
- Patients with HIV and a cell count of cluster of differentiation 4 (CD4) cells \< 50 mm2,
- Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.
- Patients with severe sepsis/septic shock transferred from another hospital
- Patients with features of sepsis/septic shock \> 24 hours
- Patients who require treatment with corticosteroids for an indication other than sepsis (chronic corticosteroid use, known Addison's Disease, Ulcerative colitis, Crohn's disease...)
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03335124
Start Date
September 26 2017
End Date
December 1 2018
Last Update
February 19 2019
Active Locations (1)
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1
Department of Gastroenterology, UMC Ljubljana
Ljubljana, Slovenia, 1000