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
About this trial
This is an interventional supportive care trial for Hyperlactatemia focused on measuring cardiac surgery, cardiopulmonary bypass, hyperlactatemia, vitamin C
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
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
NCT ID
NCT04046861
First Posted
July 27, 2019
Last Updated
December 30, 2022
Sponsor
University Medical Centre Maribor
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
Citations:
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Influence of High Vitamin C Dose on Lactate During and After Extracorporeal Circulation
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