Ascorbic Acid and Thiamine Effect in Septic Shock

• Status: Completed
• Trial end date: 2020-04-14
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy of early metabolic resuscitation with combination therapy using vitamin C and thiamine in improving organ function and survival in patients with septic shock.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tae Gun Shin
• Collaborator: National Research Foundation of Korea
• Treatments: Ascorbic Acid; Pharmaceutical Solutions; Thiamine; Vitamins

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