Status:
COMPLETED
Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
Lead Sponsor:
Community Medical Center, Toms River, NJ
Conditions:
Sepsis, Severe
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine, and hydrocortisone to the usual standard of care of sepsis and septic shock. Sepsis is a possibly life-thre...
Detailed Description
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. With more timely diagnosis and improvement...
Eligibility Criteria
Inclusion
- i. Diagnosis of sepsis or septic shock within 12 hours of admission to the ICU ii. Informed consent as dictated by IRB and local practice. iii. Compliance with the 3 hour sepsis bundle
- 30ml/kg of intravenous crystalloid fluid (e.g.: sodium chloride 0.9%) for lactic acid \>4 and/or systolic blood pressure \<90mmHg / mean arterial pressure \<65mmHg
- Lactic acid level drawn
- Broad spectrum antibiotics given after obtaining blood cultures
Exclusion
- i. Age \< 18 years ii. Pregnant iii. DNR/DNI with limitations of care on admission iv. Patients with terminal end stage disease (i.e. stage IV cancer, end stage heart failure) that are unlikely to survive to hospital discharge v. Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma \[64-66\] vi. Requirement for immediate surgery \[64-66\] vii. Patients with HIV and a CD4 \< 50 mm2 \[64-66\] viii. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.\[39\] ix. Patients with sepsis/septic shock transferred from another hospital x. Patients with features of sepsis/septic shock \> 24 hours after admission
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03422159
Start Date
February 5 2018
End Date
August 27 2019
Last Update
September 21 2021
Active Locations (2)
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1
Monmouth Medical Center, Southern Campus
Lakewood, New Jersey, United States, 08701
2
Community Medical Center
Toms River, New Jersey, United States, 08755