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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-31

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.

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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.

Conditions

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Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ascorbic acid

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.

Group Type EXPERIMENTAL

Ascorbic acid

Intervention Type DRUG

200mg/kg/24h in four equal parts

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The same regimen as ascorbic acid.

Interventions

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Ascorbic acid

200mg/kg/24h in four equal parts

Intervention Type DRUG

Placebo

The same regimen as ascorbic acid.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No