Thiamine as an adjunctive therapy in cardiac surgery: A randomized, doubleblind, placebo-controlled, phase II trial

Critical Care

Volumn 20, Issue 1, 2016, Pages

  Andersen, Lars W ^a,b   Holmberg, Mathias J ^a,b   Berg, Katherine M ^a   Chase, Maureen ^a   Cocchi, Michael N ^a   Sulmonte, Christopher ^a   Balkema, Julia ^a   MacDonald, Mary ^a   Montissol, Sophia ^a   Senthilnathan, Venkatachalam ^a   Liu, David ^a   Khabbaz, Kamal ^a   Lerner, Adam ^a   Novack, Victor ^c,d   Liu, Xiaowen ^a   Donnino, Michael W ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

^d BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

Author keywords

Aerobic; Anaerobic; Cardiac surgery; Coronary artery bypass grafting; Lactate; Metabolism; Oxygen consumption; Pyruvate dehydrogenase; Thiamine

Indexed keywords

LACTIC ACID; PLACEBO; PYRUVATE DEHYDROGENASE; THIAMINE;

ADULT; ARTICLE; CONTROLLED STUDY; CORONARY ARTERY BYPASS GRAFT; DOUBLE BLIND PROCEDURE; DRUG EFFECT; ENZYME ACTIVITY; FEMALE; HUMAN; HUMAN CELL; INTENSIVE CARE UNIT; LACTATE BLOOD LEVEL; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; OXYGEN CONSUMPTION; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 2 CLINICAL TRIAL; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; PREOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; AGED; BLOOD; DRUG EFFECTS; INTRAVENOUS DRUG ADMINISTRATION; MORTALITY; POSTOPERATIVE COMPLICATIONS; PROCEDURES;

AGED; CORONARY ARTERY BYPASS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LACTIC ACID; MALE; OXYGEN CONSUMPTION; POSTOPERATIVE COMPLICATIONS; THIAMINE;

EID: 85008622690     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/S13054-016-1245-1     Document Type: Article

References (51)

1. Hall MJ, DeFrances CJ, Williams SN, Golosinskiy A, Schwartzman A. National Hospital Discharge Survey: 2007 summary. Nat Health Stat Rep. 2010;29:1-20. 24.
2. Frost L, Molgaard H, Christiansen EH, Hjortholm K, Paulsen PK, Thomsen PE. Atrial fibrillation and flutter after coronary artery bypass surgery: epidemiology, risk factors and preventive trials. Int J Cardiol. 1992;36(3):253-61.
3. Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, et al. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012; 367(1):30-9.
4. Silber JH, Rosenbaum PR, Schwartz JS, Ross RN, Williams SV. Evaluation of the complication rate as a measure of quality of care in coronary artery bypass graft surgery. JAMA. 1995;274(4):317-23.
5. Maillet JM, Le Besnerais P, Cantoni M, Nataf P, Ruffenach A, Lessana A, et al. Frequency, risk factors, and outcome of hyperlactatemia after cardiac surgery. Chest. 2003;123(5):1361-6.
6. Toraman F, Evrenkaya S, Yuce M, Aksoy N, Karabulut H, Bozkulak Y, et al. Lactic acidosis after cardiac surgery is associated with adverse outcome. Heart Surg Forum. 2004;7(2):E155-9.
7. Hajjar LA, Almeida JP, Fukushima JT, Rhodes A, Vincent JL, Osawa EA, et al. High lactate levels are predictors of major complications after cardiac surgery. J Thorac Cardiovasc Surg. 2013;146(2):455-60.
8. Lindsay AJ, Xu M, Sessler DI, Blackstone EH, Bashour CA. Lactate clearance time and concentration linked to morbidity and death in cardiac surgical patients. Ann Thorac Surg. 2013;95(2):486-92.
9. Badreldin AM, Doerr F, Elsobky S, Brehm BR, Abul-Dahab M, Lehmann T, et al. Mortality prediction after cardiac surgery: blood lactate is indispensible. Thorac Cardiovasc Surg. 2013;61(8):708-17.
10. Andersen LW, Holmberg MJ, Doherty M, Khabbaz K, Lerner A, Berg KM, et al. Postoperative lactate levels and hospital length of stay after cardiac surgery. J Cardiothorac Vasc Anesth. 2015;29:1454-60.
11. Casserly B, Phillips GS, Schorr C, Dellinger RP, Townsend SR, Osborn TM, et al. Lactate measurements in sepsis-induced tissue hypoperfusion: results from the Surviving Sepsis Campaign database. Crit Care Med. 2015;43(3):567-73.
12. Andersen LW, Mackenhauer J, Roberts JC, Berg KM, Cocchi MN, Donnino MW. Etiology and therapeutic approach to elevated lactate levels. Mayo Clin Proc. 2013;88(10):1127-40.
13. Fink MP. Bench-to-bedside review: cytopathic hypoxia. Crit Care. 2002;6(6):491-9.
14. Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988;94(6):1176-86.
15. Rivers EP, Rady MY, Martin GB, Fenn NM, Smithline HA, Alexander ME, et al. Venous hyperoxia after cardiac arrest. Characterization of a defect in systemic oxygen utilization. Chest. 1992;102(6):1787-93.
16. Hayes MA, Timmins AC, Yau EH, Palazzo M, Hinds CJ, Watson D. Elevation of systemic oxygen delivery in the treatment of critically ill patients. N Engl J Med. 1994;330(24):1717-22.
17. Patel MS, Korotchkina LG. Regulation of the pyruvate dehydrogenase complex. Biochem Soc Trans. 2006;34(Pt 2):217-22.
18. Linn TC, Pettit FH, Reed LJ. Alpha-keto acid dehydrogenase complexes. X. Regulation of the activity of the pyruvate dehydrogenase complex from beef kidney mitochondria by phosphorylation and dephosphorylation. Proc Natl Acad Sci U S A. 1969;62(1):234-41.
19. Andersen LW, Liu X, Peng TJ, Giberson TA, Khabbaz KR, Donnino MW. Pyruvate dehydrogenase activity and quantity decreases after coronary artery bypass grafting: a prospective observational study. Shock. 2015;43(3):250-4.
20. Kobayashi K, Neely JR. Effects of ischemia and reperfusion on pyruvate dehydrogenase activity in isolated rat hearts. J Mol Cell Cardiol. 1983;15(6):359-67.
21. Patel TB, Olson MS. Regulation of pyruvate dehydrogenase complex in ischemic rat heart. Am J Physiol. 1984;246(6 Pt 2):H858-64.
22. Lewandowski ED, Johnston DL. Reduced substrate oxidation in postischemic myocardium: 13C and 31P NMR analyses. Am J Physiol. 1990;258(5 Pt 2):H1357-65.
23. Rao V, Merante F, Weisel RD, Shirai T, Ikonomidis JS, Cohen G, et al. Insulin stimulates pyruvate dehydrogenase and protects human ventricular cardiomyocytes from simulated ischemia. J Thorac Cardiovasc Surg. 1998;116(3):485-94.
24. Merante F, Mickle DA, Weisel RD, Li RK, Tumiati LC, Rao V, et al. Myocardial aerobic metabolism is impaired in a cell culture model of cyanotic heart disease. Am J Physiol. 1998;275(5 Pt 2):H1673-81.
25. Naito E, Ito M, Yokota I, Saijo T, Matsuda J, Kuroda Y. Thiamine-responsive lactic acidaemia: role of pyruvate dehydrogenase complex. Eur J Pediatr. 1998;157(8):648-52.
26. Donnino MW, Cocchi MN, Smithline H, Carney E, Chou PP, Salciccioli J. Coronary artery bypass graft surgery depletes plasma thiamine levels. Nutrition. 2010;26(1):133-6.
27. Society of Thoracic Surgeons National Database-Data Collection. Available from: http://www.sts.org/sts-national-database/database-managers/adultcardiac-surgery-database/data-collection. Accessed date Dec 22 2015.
28. Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, et al. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(7):2064-89.
29. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Third universal definition of myocardial infarction. Circulation. 2012;126(16):2020-35.
30. Force ADT, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012; 307(23):2526-33.
31. The Criteria Committee of the New York Heart Association. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994.
32. Campeau L. Letter: grading of angina pectoris. Circulation. 1976;54(3):522-3.
33. EuroSCORE II calculator. Available from: http://www.euroscore.org/calc.html. Accessed date Dec 22 2015.
34. Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg. 1999;16(1):9-13.
35. Carnero-Alcazar M, Silva Guisasola JA, Reguillo Lacruz FJ, Maroto Castellanos LC, Cobiella Carnicer J, Villagran Medinilla E, et al. Validation of EuroSCORE II on a single-centre 3800 patient cohort. Interact Cardiovasc Thorac Surg. 2013;16(3):293-300.
36. Biancari F, Vasques F, Mikkola R, Martin M, Lahtinen J, Heikkinen J. Validation of EuroSCORE II in patients undergoing coronary artery bypass surgery. Ann Thorac Surg. 2012;93(6):1930-5.
37. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-81.
38. Liu X, Pervez H, Andersen LW, Uber A, Montissol S, Patel P, et al. Immunocapture and microplate-based activity and quantity measurement of pyruvate dehydrogenase in human peripheral blood mononuclear cells. Bioanalysis. 2015;7(5):583-92.
39. Lib M, Rodriguez-Mari A, Marusich MF, Capaldi RA. Immunocapture and microplate-based activity measurement of mammalian pyruvate dehydrogenase complex. Anal Biochem. 2003;314(1):121-7.
40. McLellan S, Walsh T, Burdess A, Lee A. Comparison between the Datex-Ohmeda M-COVX metabolic monitor and the Deltatrac II in mechanically ventilated patients. Intensive Care Med. 2002;28(7):870-6.
41. Donaldson L, Dodds S, Walsh TS. Clinical evaluation of a continuous oxygen consumption monitor in mechanically ventilated patients. Anaesthesia. 2003;58(5):455-60.
42. Ferrick DA, Neilson A, Beeson C. Advances in measuring cellular bioenergetics using extracellular flux. Drug Discov Today. 2008;13(5-6):268-74.
43. Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ. 2012;345:e5840.
44. Thornalley PJ, Babaei-Jadidi R, Al Ali H, Rabbani N, Antonysunil A, Larkin J, et al. High prevalence of low plasma thiamine concentration in diabetes linked to a marker of vascular disease. Diabetologia. 2007;50(10):2164-70.
45. Larkin JR, Zhang F, Godfrey L, Molostvov G, Zehnder D, Rabbani N, et al. Glucose-induced down regulation of thiamine transporters in the kidney proximal tubular epithelium produces thiamine insufficiency in diabetes. PLoS One. 2012;7(12):e53175.
46. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325(7365):652-4.
47. Luger M, Hiesmayr M, Koppel P, Sima B, Ranz I, Weiss C, et al. Influence of intravenous thiamine supplementation on blood lactate concentration prior to cardiac surgery: a double-blinded, randomised controlled pilot study. Eur J Anaesthesiol. 2015;32(8):543-8.
48. Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, et al. Randomized, double-blind, placebo-controlled trial of thiamine as a metabolic resuscitator in septic shock: a pilot study. Crit Care Med. 2016;44(2):360-7.
49. Atherton HJ, Schroeder MA, Dodd MS, Heather LC, Carter EE, Cochlin LE, et al. Validation of the in vivo assessment of pyruvate dehydrogenase activity using hyperpolarised 13C MRS. NMR Biomed. 2011;24(2):201-8.
50. Berg KM, Gautam S, Salciccioli JD, Giberson T, Saindon B, Donnino MW. Intravenous thiamine is associated with increased oxygen consumption in critically ill patients with preserved cardiac index. Ann Am Thorac Soc. 2014;11(10):1597-601.
51. Garcia-Alvarez M, Marik P, Bellomo R. Sepsis-associated hyperlactatemia. Crit Care. 2014;18(5):503.