Status:
COMPLETED
Ascorbic Acid and Thiamine Effect in Septic Shock
Lead Sponsor:
Tae Gun Shin
Collaborating Sponsors:
National Research Foundation of Korea
Conditions:
Septic Shock
Sepsis
Eligibility:
All Genders
19-89 years
Phase:
PHASE2
Brief 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 septi...
Detailed Description
Sepsis is a complex disease involving life-threatening organ dysfunction caused by a dysregulated host response to infection and is still associated with unacceptably high mortality. Sepsis management...
Eligibility Criteria
Inclusion
- Adult patients (\> 18 years)
- 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
- Transferred patients from other hospitals after application of vasopressors or mechanical ventilation
- Patients who signed a "Do not attempt resuscitation" order or who had set limitations on invasive care
- Patients who have a terminal, unresponsive illness and survival discharge is not expected (metastatic terminal cancer, etc.)
- Patients who experienced cardiac arrest before enrollment or when death is anticipated within 24 hours despite maximal treatment
- Patients who take more than 1g of Vitamin C per day before enrollment or who take supplemental thiamine
- Pregnant woman
- Known Glucose-6-phosphate dehydrogenase deficiency
- Patients with a history of hypersensitivity to vitamin C or thiamine
- Known Mediterranean anemia
- Known hyperoxaluria
- Known cystinuria
- Acute gout attack
- Known oxalate renal stone
- 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
- Inability or refusal of a subject or legal surrogate to give informed consent
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2020
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03756220
Start Date
December 1 2018
End Date
April 14 2020
Last Update
October 28 2020
Active Locations (6)
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1
Department of Emergency Medicine, Seoul National University Bundang Hospital,
Seongnam-si, Gyeonggi-do, South Korea
2
Department of Emergency Medicine, Borame Medical Center, Seoul National University, College of Medicine
Seoul, South Korea
3
Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine,
Seoul, South Korea
4
Department of Emergency Medicine, Seoul National University College of Medicine,
Seoul, South Korea