NCT04046861

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
3.6 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

July 27, 2019

Last Update Submit

February 19, 2025

Conditions

HyperlactatemiaCardiac DiseaseBypass ComplicationValve Disease, HeartVitamin C

Keywords

cardiac surgerycardiopulmonary bypasshyperlactatemiavitamin C

Outcome Measures

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

    up to 30 hours

Secondary Outcomes (1)

  • dose of noradrenaline and other vasopressors

    up to 36 hours

Other Outcomes (1)

  • Concentration of glucose

    up to 30 hours

Study Arms (2)

Vitamin C

ACTIVE COMPARATOR

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 (saline)

PLACEBO COMPARATOR

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

ascorbic acid,DIETARY_SUPPLEMENT

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
Vitamin C
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

Placebo (saline)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department od anesthesiology, intensive care and pain management

Maribor, 2000, Slovenia

Location

Related Publications (21)

  • 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.

    PMID: 12131125BACKGROUND

  • 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.

    PMID: 27490610BACKGROUND

  • 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.

    PMID: 23276596BACKGROUND

  • 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.

    PMID: 28592639BACKGROUND

  • 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.

    PMID: 27312081BACKGROUND

  • 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.

    PMID: 26847748BACKGROUND

  • 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.

    PMID: 28701592BACKGROUND

  • 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.

    PMID: 27671216BACKGROUND

  • 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.

    PMID: 30060468BACKGROUND

  • 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.

    PMID: 22813486BACKGROUND

  • 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.

    PMID: 15131240BACKGROUND

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

    PMID: 12122132BACKGROUND

  • 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.

    PMID: 16810041BACKGROUND

  • 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.

    PMID: 21037469BACKGROUND

  • 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.

    PMID: 12740248BACKGROUND

  • 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.

    PMID: 10667509BACKGROUND

  • 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.

    PMID: 2244489BACKGROUND

  • 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.

    PMID: 25635594BACKGROUND

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

    PMID: 28661424BACKGROUND

  • 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.

    PMID: 25185110BACKGROUND

  • 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.

    PMID: 7863489BACKGROUND

MeSH Terms

Conditions

HyperlactatemiaHeart DiseasesHeart Valve Diseases

Interventions

Ascorbic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assistant professor

Study Record Dates

First Submitted

July 27, 2019

First Posted

August 6, 2019

Study Start

March 1, 2023

Primary Completion

December 1, 2023

Study Completion

September 1, 2024

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)