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Completed

NCT Number: NCT04046861

Influence of High Vitamin C Dose on Lactate During and After Extracorporeal Circulation

The aim of our study is to find out whether high doses of vitamin C before cardiopulmonary bypass and during the first 24 hours after that have and impact of lowering the incidence of hyperlactatemia.

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Key information

Conditions

Hyperlactatemia Bypass Complication Cardiac Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Valve Disease, Heart Vitamin C

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department od anesthesiology, intensive care and pain management

Maribor, 2000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years old patients with cardiac disease needing surgery (coronary bypass, valve replacement)

Exclusion criteria

  • dementia
  • kidney stones
  • dialysis
  • haemochromatosis
  • thalassemias
  • G-6-P deficiency

Treatment and study plan

ascorbic acid,

Dietary Supplement

The vitamin C group will get high dose of intravenous vitamin C (ascorbic acid) before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours

Other names: Vitamin C

placebo (saline)

Other

The placebo group will get saline before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours

Primary outcomes

  1. Concentration of lactate

    Time frame: up to 30 hours

    Measuring the concentration of lactate before cardiopulmonary bypass, after aortic clamp removal, at ICU admission,then every 6 hours

Secondary outcomes

  1. dose of noradrenaline and other vasopressors

    Time frame: up to 36 hours

    The need for noradrenaline and other vasopressors (e.g. vasopresin) during the surgery and in the 24-hours after the end of the surgery

Other outcomes

  1. Concentration of glucose

    Time frame: up to 30 hours

    Measuring the concentration of glucose before cardiopulmonary bypass, after aortic clamp removal, at ICU admission, then every 6 hours

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Official study title

"Influence of High Vitamin C Dose on Lactate During Extracorporeal Circulation for Heart Surgery and During the 24 Hours Thereafter." (double Blind Prospective Randomised Study)

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 6, 2019
Registry last updated
Feb 21, 2025

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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