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NCT04773717 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04773717
Other study ID # BE-2-5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date January 31, 2021

Study information
Verified date February 2021
Source Lithuanian University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Lithuania Lithuanian University of Health Sciences Hospital Kaunas Clinics Kaunas

Sponsors (1)
Lead Sponsor Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microvascular flow index (MFI) Changes in MFI Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Primary Proportion of perfused small vessels (PPV) Changes in PPV Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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