Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Microcirculation, Ascorbic acid
Brief summary
The purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.
Detailed description
Adult patients with septic shock were enrolled within 24 hours following admission to the Central Department of Intensive Care in Lithuanian University of Health Sciences Hospital Kaunas Clinics. Participants were randomly assigned to a placebo or ascorbic acid group in a 1:1 ratio. They were resuscitated according to Surviving Sepsis Campaign Guidelines. Additionally, they received an intravenous infusion of ascorbic acid either placebo. The dose of ascorbic acid was 200mg/kg/24h divided into four equal parts for 96 hours. Sublingual microcirculatory measurements were obtained, using an incident dark field (IDF) device.
Interventions
DRUGAscorbic acid
200mg/kg/24h in four equal parts
DRUGPlacebo
The same regimen as ascorbic acid.
Sponsors
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with sepsis or septic shock within the first 24 hours after ICU admission.
Exclusion criteria
* Age \< 18 years, * Pregnancy, * Advanced malignancy, * History of kidney stone, glucose-6-phosphate deficiency, hemochromatosis, or solid organ transplantation, * Oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular flow index (MFI) | Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours | Changes in MFI |
| Proportion of perfused small vessels (PPV) | Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours | Changes in PPV |
Countries
Lithuania
Outcome results
None listed