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

Not Applicable

Completed

• Conditions: Sepsis; Septic Shock
• Interventions: Drug: Ascorbic acid; Drug: Placebo

• Registration Number: NCT04773717
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-26
• Last Update Submitted: 2021-02-28
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ascorbic acid	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	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lithuanian University of Health Sciences Hospital Kaunas Clinics; 🇱🇹 Kaunas, Lithuania