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Completed

NCT Number: NCT04773717

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

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences Hospital Kaunas Clinics

Kaunas, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ascorbic acid

Drug

200mg/kg/24h in four equal parts

Placebo

Drug

The same regimen as ascorbic acid.

Primary outcomes

  1. Microvascular flow index (MFI)

    Time frame: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours

    Changes in MFI

  2. Proportion of perfused small vessels (PPV)

    Time frame: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours

    Changes in PPV

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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