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

Lithuanian University of Health Sciences

Status: Completed

Conditions: Septic Shock; Sepsis

Treatments: Drug: Placebo; Drug: Ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04773717

BE-2-5

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Ascorbic acid

Experimental group

Description:

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.

Treatment:

Drug: Ascorbic acid

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo