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

December 30, 2022 updated by: Andreja Möller Petrun, MD, PhD, University Medical Centre Maribor

"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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andreja Möller Petrun, PhD
  • Phone Number: 0038623211571
  • Email: drejapet@web.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin C
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,
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 Comparator: Placebo (saline)
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)
The placebo group will get saline before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 36 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

July 27, 2019

First Submitted That Met QC Criteria

August 3, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKC-MB-KME-20/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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