- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773717
The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis
The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania
- Lithuanian University of Health Sciences Hospital Kaunas Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. |
200mg/kg/24h in four equal parts
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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.
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The same regimen as ascorbic acid.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular flow index (MFI)
Time Frame: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Changes in MFI
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Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Proportion of perfused small vessels (PPV)
Time Frame: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Changes in PPV
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Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE-2-5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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