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

Cardiac Disease Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04046861
• Other study ID #: UKC-MB-KME-20/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2022
• Source: University Medical Centre Maribor
• Contact: Andreja Möller Petrun, PhD
• Phone: 0038623211571
• Email: drejapet[@]web.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Maribor

References & Publications (21)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tyml K. Vitamin C and Microvascular Dysfunction in Systemic Inflammation. Antioxidants (Basel). 2017 Jun 29;6(3):49. doi: 10.3390/antiox6030049. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of glucose	Measuring the concentration of glucose before cardiopulmonary bypass, after aortic clamp removal, at ICU admission, then every 6 hours	up to 30 hours
Primary	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	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