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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hyperlactatemia, Cardiac Disease, Bypass Complication, Valve Disease, Heart, Vitamin C

Intervention / Treatment
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* Dietary Supplement: ascorbic acid,
* Other: Placebo (saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin C<br>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) | Dietary Supplement: ascorbic acid,<br>* 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<br>* Other names: Vitamin C;|
| Placebo Comparator: Placebo (saline)<br>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) | Other: Placebo (saline)<br>* The placebo group will get saline before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of lactate | Measuring the concentration of lactate before cardiopulmonary bypass, after aortic clamp removal, at ICU admission,then every 6 hours | up to 30 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, cardiopulmonary bypass, hyperlactatemia, vitamin C