The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable sepsis
Started Jan 2019
Typical duration for not_applicable sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFirst Submitted
Initial submission to the registry
February 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedMarch 3, 2021
February 1, 2021
2.1 years
February 21, 2021
February 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Microvascular flow index (MFI)
Changes in MFI
Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Proportion of perfused small vessels (PPV)
Changes in PPV
Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Study Arms (2)
Ascorbic acid
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with sepsis or septic shock within the first 24 hours after ICU admission.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lithuanian University of Health Sciences Hospital Kaunas Clinics
Kaunas, Lithuania
Related Publications (1)
Belousoviene E, Pranskuniene Z, Vaitkaitiene E, Pilvinis V, Pranskunas A. Effect of high-dose intravenous ascorbic acid on microcirculation and endothelial glycocalyx during sepsis and septic shock: a double-blind, randomized, placebo-controlled study. BMC Anesthesiol. 2023 Sep 12;23(1):309. doi: 10.1186/s12871-023-02265-z.
PMID: 37700249DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 21, 2021
First Posted
February 26, 2021
Study Start
January 1, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
March 3, 2021
Record last verified: 2021-02