CClinicalTrials.gg
CompletedNCT04046861Updated Feb 21, 2025

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

An interventional study of ascorbic acid, and Placebo (saline) in Hyperlactatemia, Cardiac Disease and Bypass Complication, sponsored by University Medical Centre Maribor. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by University Medical Centre Maribor · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • cardiac surgery
  • cardiopulmonary bypass
  • hyperlactatemia
  • vitamin C
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • dementia
  • kidney stones
  • dialysis
  • haemochromatosis
  • thalassemias
  • G-6-P deficiency
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (actual)

Study arms

  • 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,

  • 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)

Interventions

  • Dietary supplementascorbic 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

    Also known as: Vitamin C

  • OtherPlacebo (saline)

    The placebo group will get saline before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours

05

What researchers measure

Primary outcomes

  1. Concentration of lactate

    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 outcomes

  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

    Time frame: up to 36 hours

Other outcomes

  1. Concentration of glucose

    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

06

Study locations

1 site
  • Department od anesthesiology, intensive care and pain management
    Maribor, 2000, Slovenia
07

References and documents

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 ↗
  • Levy B, Sadoune LO, Gelot AM, Bollaert PE, Nabet P, Larcan A. Evolution of lactate/pyruvate and arterial ketone body ratios in the early course of catecholamine-treated septic shock. Crit Care Med. 2000 Jan;28(1):114-9. doi: 10.1097/00003246-200001000-00019. PubMed 10667509 ↗
  • Frei B, Stocker R, England L, Ames BN. Ascorbate: the most effective antioxidant in human blood plasma. Adv Exp Med Biol. 1990;264:155-63. doi: 10.1007/978-1-4684-5730-8_24. PubMed 2244489 ↗
  • Berger MM, Oudemans-van Straaten HM. Vitamin C supplementation in the critically ill patient. Curr Opin Clin Nutr Metab Care. 2015 Mar;18(2):193-201. doi: 10.1097/MCO.0000000000000148. PubMed 25635594 ↗
  • Tyml K. Vitamin C and Microvascular Dysfunction in Systemic Inflammation. Antioxidants (Basel). 2017 Jun 29;6(3):49. doi: 10.3390/antiox6030049. PubMed 28661424 ↗
  • Oudemans-van Straaten HM, Spoelstra-de Man AM, de Waard MC. Vitamin C revisited. Crit Care. 2014 Aug 6;18(4):460. doi: 10.1186/s13054-014-0460-x. PubMed 25185110 ↗
  • Dingchao H, Zhiduan Q, Liye H, Xiaodong F. The protective effects of high-dose ascorbic acid on myocardium against reperfusion injury during and after cardiopulmonary bypass. Thorac Cardiovasc Surg. 1994 Oct;42(5):276-8. doi: 10.1055/s-2007-1016504. PubMed 7863489 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04046861
Lead sponsor
University Medical Centre Maribor
Responsible party
Andreja Möller Petrun, MD, PhD (MD, PhD, Assistant professor, University Medical Centre Maribor) — Principal investigator
First posted
Aug 6, 2019
Start date
Mar 1, 2023
Primary completion
Dec 1, 2023
Completion
Sep 1, 2024
Last update
Feb 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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