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

Overview

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

Full Title of Study: “The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2021

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

  • Drug: Ascorbic acid
    • 200mg/kg/24h in four equal parts
  • Drug: Placebo
    • The same regimen as ascorbic acid.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lithuanian University of Health Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrius Pranskunas, Professor – Lithuanian University of Health Sciences

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