Overview

The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

Status:
Terminated
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
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 desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Medical Centre Ljubljana
Treatments:
Ascorbic Acid
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Thiamine
Vitamins
Criteria
Inclusion Criteria:

- Diagnosis of severe sepsis or septic shock within 12 hours of admission in our
Intensive Care Unit (ICU).

- Informed consent.

Exclusion Criteria:

- 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...)