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

Primary Purpose

Hyperlactatemia, Cardiac Disease, Bypass Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ascorbic acid,
Placebo (saline)
Sponsored by
University Medical Centre Maribor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperlactatemia focused on measuring cardiac surgery, cardiopulmonary bypass, hyperlactatemia, vitamin C

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Vitamin C

    Placebo (saline)

    Arm Description

    2g vitamin C (ascorbic acid) iv before cardiopulmonary bypass, 2 g vitamin C iv before removing the aortic clamp, 1g vitamin C iv 8 h after aortic clamp removal and every 8 h thereafter(2 times)

    placebo (saline) iv before cardiopulmonary bypass, placebo before removing the aortic clamp, placebo iv 8 h after aortic clamp removal and every 8 h (2 times)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 27, 2019
    Last Updated
    December 30, 2022
    Sponsor
    University Medical Centre Maribor
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04046861
    Brief Title
    Influence of High Vitamin C Dose on Lactate During and After Extracorporeal Circulation
    Official 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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Centre Maribor

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlactatemia, Cardiac Disease, Bypass Complication, Valve Disease, Heart, Vitamin C
    Keywords
    cardiac surgery, cardiopulmonary bypass, hyperlactatemia, vitamin C

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin C
    Arm Type
    Active Comparator
    Arm Description
    2g vitamin C (ascorbic acid) iv before cardiopulmonary bypass, 2 g vitamin C iv before removing the aortic clamp, 1g vitamin C iv 8 h after aortic clamp removal and every 8 h thereafter(2 times)
    Arm Title
    Placebo (saline)
    Arm Type
    Placebo Comparator
    Arm Description
    placebo (saline) iv before cardiopulmonary bypass, placebo before removing the aortic clamp, placebo iv 8 h after aortic clamp removal and every 8 h (2 times)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    ascorbic acid,
    Other Intervention Name(s)
    Vitamin C
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Placebo (saline)
    Intervention Description
    The placebo group will get saline before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours
    Primary Outcome Measure Information:
    Title
    Concentration of lactate
    Description
    Measuring the concentration of lactate before cardiopulmonary bypass, after aortic clamp removal, at ICU admission,then every 6 hours
    Time Frame
    up to 30 hours
    Secondary Outcome Measure Information:
    Title
    dose of noradrenaline and other vasopressors
    Description
    The need for noradrenaline and other vasopressors (e.g. vasopresin) during the surgery and in the 24-hours after the end of the surgery
    Time Frame
    up to 36 hours
    Other Pre-specified Outcome Measures:
    Title
    Concentration of glucose
    Description
    Measuring the concentration of glucose before cardiopulmonary bypass, after aortic clamp removal, at ICU admission, then every 6 hours
    Time Frame
    up to 30 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andreja Möller Petrun, PhD
    Phone
    0038623211571
    Email
    drejapet@web.de

    12. IPD Sharing Statement

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

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