The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.

Detailed Description
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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.

Official Title
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The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial

Conditions
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Sepsis, Septic Shock

Intervention / Treatment
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* Drug: Ascorbic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascorbic acid<br>Patients received a high dose of intravenous ascorbic acid in four equal parts daily for 96 hours. Images of sublingual microcirculation were obtained at a baseline, after 0.5, 6, 12, 24, 48, 72, and 96 hours. | Drug: Ascorbic acid<br>* 200mg/kg/24h in four equal parts<br>|
| Placebo Comparator: Placebo<br>Patients received placebo solution matching ascorbic acid solution as four equal parts daily for 96 hours. Images of sublingual microcirculation were obtained at a baseline, after 0.5, 6, 12, 24, 48, 72, and 96 hours. | Drug: Placebo<br>* The same regimen as ascorbic acid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular flow index (MFI) | Changes in MFI | Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours | 
| Proportion of perfused small vessels (PPV) | Changes in PPV | Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Microcirculation, Ascorbic acid