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HyperlactatemiaNCT04046861

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

A study testing ascorbic acid, in people with Hyperlactatemia and Cardiac Disease, run by University Medical Centre Maribor at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
ascorbic acid,
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteSlovenia
Study dates
1 Mar 2023to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Department od anesthesiology, intensive care and pain management

    Maribor, 2000

Other trials in Slovenia

About this study

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)

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.

Being tested
ascorbic acid,, Placebo (saline)
Keywords
cardiac surgery, cardiopulmonary bypass, hyperlactatemia, vitamin C
Medical subject headings
Hyperlactatemia, Heart Diseases, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ascorbic acid,Dietary supplement

    Also called Vitamin C

    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

  • 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

Study groups in NCT04046861
Study groupRoleWhat they receive
Vitamin CActive comparator2g 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)
Receives: Dietary Supplement: ascorbic acid,
Placebo (saline)Placebo comparatorplacebo (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)
Receives: Other: Placebo (saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of lactate

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

    Measured: up to 30 hours

Secondary outcomes (1)

  1. 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

    Measured: up to 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start1 Mar 2023
  3. Primary completion1 Dec 2023
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046861
Sponsor's protocol ID
UKC-MB-KME-20/19
Status last verified
Feb 2025
First submitted
27 Jul 2019
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laffey JG, Boylan JF, Cheng DC. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology. 2002 Jul;97(1):215-52. doi: 10.1097/00000542-200207000-00030. No abstract available.

    PubMed 12131125

  • Bronicki RA, Hall M. Cardiopulmonary Bypass-Induced Inflammatory Response: Pathophysiology and Treatment. Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S272-8. doi: 10.1097/PCC.0000000000000759.

    PubMed 27490610

  • Hall R. Identification of inflammatory mediators and their modulation by strategies for the management of the systemic inflammatory response during cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Oct;27(5):983-1033. doi: 10.1053/j.jvca.2012.09.013. Epub 2012 Dec 29. No abstract available.

    PubMed 23276596

  • Roy J, Galano JM, Durand T, Le Guennec JY, Lee JC. Physiological role of reactive oxygen species as promoters of natural defenses. FASEB J. 2017 Sep;31(9):3729-3745. doi: 10.1096/fj.201700170R. Epub 2017 Jun 7.

    PubMed 28592639

  • Koekkoek WA, van Zanten AR. Antioxidant Vitamins and Trace Elements in Critical Illness. Nutr Clin Pract. 2016 Aug;31(4):457-74. doi: 10.1177/0884533616653832. Epub 2016 Jun 16.

    PubMed 27312081

  • Stoppe C, McDonald B, Benstoem C, Elke G, Meybohm P, Whitlock R, Fremes S, Fowler R, Lamarche Y, Jiang X, Day AG, Heyland DK. Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):30-8. doi: 10.1053/j.jvca.2015.07.035. Epub 2015 Jul 29.

    PubMed 26847748

  • Ellenberger C, Sologashvili T, Cikirikcioglu M, Verdon G, Diaper J, Cassina T, Licker M. Risk factors of postcardiotomy ventricular dysfunction in moderate-to-high risk patients undergoing open-heart surgery. Ann Card Anaesth. 2017 Jul-Sep;20(3):287-296. doi: 10.4103/aca.ACA_60_17.

    PubMed 28701592

  • Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.

    PubMed 27671216

  • Hill A, Wendt S, Benstoem C, Neubauer C, Meybohm P, Langlois P, Adhikari NK, Heyland DK, Stoppe C. Vitamin C to Improve Organ Dysfunction in Cardiac Surgery Patients-Review and Pragmatic Approach. Nutrients. 2018 Jul 27;10(8):974. doi: 10.3390/nu10080974.

    PubMed 30060468

  • O'Connor E, Fraser JF. The interpretation of perioperative lactate abnormalities in patients undergoing cardiac surgery. Anaesth Intensive Care. 2012 Jul;40(4):598-603. doi: 10.1177/0310057X1204000404.

    PubMed 22813486

  • Gladden LB. Lactate metabolism: a new paradigm for the third millennium. J Physiol. 2004 Jul 1;558(Pt 1):5-30. doi: 10.1113/jphysiol.2003.058701. Epub 2004 May 6.

    PubMed 15131240

  • Chatham JC. Lactate -- the forgotten fuel! J Physiol. 2002 Jul 15;542(Pt 2):333. doi: 10.1113/jphysiol.2002.020974. No abstract available.

    PubMed 12122132

  • Levy B. Lactate and shock state: the metabolic view. Curr Opin Crit Care. 2006 Aug;12(4):315-21. doi: 10.1097/01.ccx.0000235208.77450.15.

    PubMed 16810041

  • Levy B, Perez P, Perny J, Thivilier C, Gerard A. Comparison of norepinephrine-dobutamine to epinephrine for hemodynamics, lactate metabolism, and organ function variables in cardiogenic shock. A prospective, randomized pilot study. Crit Care Med. 2011 Mar;39(3):450-5. doi: 10.1097/CCM.0b013e3181ffe0eb.

    PubMed 21037469

  • Maillet JM, Le Besnerais P, Cantoni M, Nataf P, Ruffenach A, Lessana A, Brodaty D. Frequency, risk factors, and outcome of hyperlactatemia after cardiac surgery. Chest. 2003 May;123(5):1361-6. doi: 10.1378/chest.123.5.1361.

    PubMed 12740248

Questions about this trial

What is this clinical trial studying?

A study testing ascorbic acid, in people with Hyperlactatemia and Cardiac Disease, run by University Medical Centre Maribor at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of lactate (time frame: up to 30 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04046861, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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