Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03756220
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (\> 18 years)
2. Septic shock: sepsis with persisting hypotension requiring vasopressors to maintain a mean arterial pressure ≥65 mm Hg and a serum lactate level \>2 mmol/L despite adequate volume resuscitation. Sepsis is defined as clinically suspected or confirmed infection with acute organ failure identified as an acute change in total SOFA score with 2 points or more.
Exclusion Criteria:
1. Transferred patients from other hospitals after application of vasopressors or mechanical ventilation
2. Patients who signed a "Do not attempt resuscitation" order or who had set limitations on invasive care
3. Patients who have a terminal, unresponsive illness and survival discharge is not expected (metastatic terminal cancer, etc.)
4. Patients who experienced cardiac arrest before enrollment or when death is anticipated within 24 hours despite maximal treatment
5. Patients who take more than 1g of Vitamin C per day before enrollment or who take supplemental thiamine
6. Pregnant woman
7. Known Glucose-6-phosphate dehydrogenase deficiency
8. Patients with a history of hypersensitivity to vitamin C or thiamine
9. Known Mediterranean anemia
10. Known hyperoxaluria
11. Known cystinuria
12. Acute gout attack
13. Known oxalate renal stone
14. Patients who meet the inclusion criteria 24 hours after emergency department arrival or when enrollment is delayed more than 24 hours after diagnosis of septic shock
15. Inability or refusal of a subject or legal surrogate to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
89 Years
Study:
NCT03756220
Study Brief:
Protocol Section:
NCT03756220