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

Primary Purpose

Sepsis, Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Ascorbic acid
Placebo
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Microcirculation, Ascorbic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lithuanian University of Health Sciences Hospital Kaunas Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ascorbic acid

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Microvascular flow index (MFI)
Changes in MFI
Proportion of perfused small vessels (PPV)
Changes in PPV

Secondary Outcome Measures

Full Information

First Posted
February 21, 2021
Last Updated
February 28, 2021
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04773717
Brief Title
The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis
Official Title
The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
Sepsis, Microcirculation, Ascorbic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ascorbic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ascorbic acid
Intervention Description
200mg/kg/24h in four equal parts
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The same regimen as ascorbic acid.
Primary Outcome Measure Information:
Title
Microvascular flow index (MFI)
Description
Changes in MFI
Time Frame
Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Title
Proportion of perfused small vessels (PPV)
Description
Changes in PPV
Time Frame
Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lithuanian University of Health Sciences Hospital Kaunas Clinics
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

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

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