The Thiamine Administration After Cardiac Surgery Trial

Thiamine Deficiency Clinical Trial

— TAACS  

Official title:

The Thiamine Administration After Cardiac Surgery Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641104
• Other study ID #: TAACS trial
• Status: Completed
• Phase: Phase 4
• Start date: November 20, 2020
• Est. completion date: October 3, 2022

Study information

• Verified date: November 2022
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose. We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

Description:

Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose. Thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as Wernicke's encephalopathy or Beri-Beri syndrome. Thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. An increase in lactate levels is associated with a worse prognostic. A decrease is, on the contrary, associated with an improved prognostic, during CPR and also after cardiac arrest. Recently, studies have shown that thiamine deficiency is underdiagnosed in ICU patients. On top of this, extra-corporeal circulation can worsen this deficiency. This could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion Donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of ICU admission and improved mortality rates at 28 days post-ICU admission. Therefore, the hypothesis of this study is that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the CHU de Charleroi between November 2020 and December 2021. Written informed consent will be obtained from each patient/ family member participating in the study.

Exclusion Criteria:

• Patients already supplemented with vitamins
• Patients with an allergy to thiamine
• Patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively
• Patients with mitochondrial disorders
• Patients with Child Pugh C cirrhosis
• Patients with a history of epilepsy with tonic-clonic movements postoperatively.
• Pregnant patients

Related Conditions & MeSH terms

• Beriberi
• Hyperlactatemia
• Lactate Blood Increase
• Thiamine Deficiency

Intervention

Drug:
• Thiamine 500 MG
A solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% will be administered post-cardiac surgery in patients with lactate levels = 2 mmol / L in the first 6 hours post-ICU admission.
• Placebo
100 ml of NaCl 0.9% will be administered in the placebo group.

Locations

Country	Name	City	State
Belgium	CHU-Charleroi Hopital Civil Marie Curie	Charleroi	Hainaut

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Saxena	CHU de Charleroi

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

Casserly B, Phillips GS, Schorr C, Dellinger RP, Townsend SR, Osborn TM, Reinhart K, Selvakumar N, Levy MM. Lactate measurements in sepsis-induced tissue hypoperfusion: results from the Surviving Sepsis Campaign database. Crit Care Med. 2015 Mar;43(3):567 — View Citation

Collie JTB, Greaves RF, Jones OAH, Lam Q, Eastwood GM, Bellomo R. Vitamin B1 in critically ill patients: needs and challenges. Clin Chem Lab Med. 2017 Oct 26;55(11):1652-1668. doi: 10.1515/cclm-2017-0054. Review. — View Citation

Costa NA, Gut AL, de Souza Dorna M, Pimentel JA, Cozzolino SM, Azevedo PS, Fernandes AA, Zornoff LA, de Paiva SA, Minicucci MF. Serum thiamine concentration and oxidative stress as predictors of mortality in patients with septic shock. J Crit Care. 2014 A — View Citation

Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscit — View Citation

Donnino MW, Carney E, Cocchi MN, Barbash I, Chase M, Joyce N, Chou PP, Ngo L. Thiamine deficiency in critically ill patients with sepsis. J Crit Care. 2010 Dec;25(4):576-81. doi: 10.1016/j.jcrc.2010.03.003. Epub 2010 Jun 19. — View Citation

Donnino MW, Miller J, Goyal N, Loomba M, Sankey SS, Dolcourt B, Sherwin R, Otero R, Wira C. Effective lactate clearance is associated with improved outcome in post-cardiac arrest patients. Resuscitation. 2007 Nov;75(2):229-34. Epub 2007 Jun 20. — View Citation

Flannery AH, Adkins DA, Cook AM. Unpeeling the Evidence for the Banana Bag: Evidence-Based Recommendations for the Management of Alcohol-Associated Vitamin and Electrolyte Deficiencies in the ICU. Crit Care Med. 2016 Aug;44(8):1545-52. doi: 10.1097/CCM.00 — View Citation

Frank RA, Leeper FJ, Luisi BF. Structure, mechanism and catalytic duality of thiamine-dependent enzymes. Cell Mol Life Sci. 2007 Apr;64(7-8):892-905. Review. — View Citation

Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial — View Citation

Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. — View Citation

Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e3 — View Citation

Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. — View Citation

Nichol AD, Egi M, Pettila V, Bellomo R, French C, Hart G, Davies A, Stachowski E, Reade MC, Bailey M, Cooper DJ. Relative hyperlactatemia and hospital mortality in critically ill patients: a retrospective multi-centre study. Crit Care. 2010;14(1):R25. doi — View Citation

Pan J, Peng M, Liao C, Hu X, Wang A, Li X. Relative efficacy and safety of early lactate clearance-guided therapy resuscitation in patients with sepsis: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14453. doi: 10.1097/MD.0000000000014453. Review — View Citation

Sterling SA, Puskarich MA, Shapiro NI, Trzeciak S, Kline JA, Summers RL, Jones AE; Emergency Medicine Shock Research Network (EMSHOCKNET). Characteristics and outcomes of patients with vasoplegic versus tissue dysoxic septic shock. Shock. 2013 Jul;40(1):1 — View Citation

Vellinga NAR, Boerma EC, Koopmans M, Donati A, Dubin A, Shapiro NI, Pearse RM, van der Voort PHJ, Dondorp AM, Bafi T, Fries M, Akarsu-Ayazoglu T, Pranskunas A, Hollenberg S, Balestra G, van Iterson M, Sadaka F, Minto G, Aypar U, Hurtado FJ, Martinelli G, — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate	Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.	24 hours
Secondary	Fluid balance	The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated	48 hours
Secondary	Inotropes	The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated	48 hours
Secondary	Mechanical ventilation	The influence of thiamine/ placebo on extubation time will also be evaluated.	48 hours
Secondary	Length of ICU stay	The influence of thiamine/ placebo on ICU discharge will also be evaluated.	5 days
Secondary	Length of hospital stay	The influence of thiamine/ placebo on hospital discharge will also be evaluated.	30 days