Perioperative fluid therapy with tetrastarch and gelatin in cardiac surgery - A prospective sequential analysis

Critical Care Medicine

Volumn 41, Issue 11, 2013, Pages 2532-2542

  Bayer, Ole ^a   Schwarzkopf, Daniel ^a   Doenst, Torsten ^a   Cook, Deborah ^b   Kabisch, Bjoern ^a   Schelenz, Christoph ^a   Bauer, Michael ^a   Riedemann, Niels C ^a   Sakr, Yasser ^a   Kohl, Matthias ^c   Reinhart, Konrad ^a   Hartog, Christiane S ^a  

^a JENA UNIVERSITY HOSPITAL   (Germany)

^b MCMASTER UNIVERSITY   (Canada)

^c FURTWANGEN UNIVERSITY   (Germany)

Author keywords

Cardiac surgery; Fluid balance; Kidney; Patient outcomes; Plasma substitutes; Renal failure; Synthetic colloids

Indexed keywords

ADRENALIN; APROTININ; FRESH FROZEN PLASMA; GELATIN; HETASTARCH; IODINATED CONTRAST MEDIUM; LACTIC ACID; NORADRENALIN; THROMBOCYTE CONCENTRATE;

ADULT; AGED; ARTICLE; ARTIFICIAL VENTILATION; CARDIOPULMONARY BYPASS; CARDIOVASCULAR MORTALITY; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRYSTALLOID; FEMALE; FLUID BALANCE; FLUID INTAKE; FLUID RESUSCITATION; FLUID THERAPY; HEART HEMODYNAMICS; HUMAN; INTENSIVE CARE UNIT; KIDNEY FAILURE; LACTATE BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MEAN ARTERIAL PRESSURE; OBSERVATIONAL STUDY; OPERATING ROOM; OUTCOME ASSESSMENT; PERIOPERATIVE PERIOD; PRIORITY JOURNAL; PROPENSITY SCORE; PROSPECTIVE STUDY; RENAL REPLACEMENT THERAPY; SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE; SIMPLIFIED ACUTE PHYSIOLOGY SCORE;

AGED; CARDIAC SURGICAL PROCEDURES; FEMALE; FLUID THERAPY; GELATIN; HEMODYNAMICS; HOSPITAL MORTALITY; HUMANS; HYDROXYETHYL STARCH DERIVATIVES; INTENSIVE CARE UNITS; ISOTONIC SOLUTIONS; MALE; MIDDLE AGED; PERIOPERATIVE CARE; PROSPECTIVE STUDIES; RENAL INSUFFICIENCY; RENAL REPLACEMENT THERAPY; WATER-ELECTROLYTE BALANCE;

EID: 84887105893     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e3182978fb6     Document Type: Article

References (50)

1. Weiser TG, Regenbogen SE, Thompson KD, et al: An estimation of the global volume of surgery: A modelling strategy based on available data. Lancet 2008; 372:139-144
2. Rackow EC, Falk JL, Fein IA, et al: Fluid resuscitation in circulatory shock: A comparison of the cardiorespiratory effects of albumin, hetastarch, and saline solutions in patients with hypovolemic and septic shock. Crit Care Med 1983; 11:839-850
3. Puyana JC: Resuscitation of hypovolemic shock. In: Textbook of Critical Care. Fifth Edition. Fink M, Abraham E, Vincent JL, et al (Eds). Philadelphia, Elsevier Saunders, 2005, pp 1939-1940
4. Finfer S, Liu B, Taylor C, et al; SAFE TRIPS Investigators: Resuscitation fluid use in critically ill adults: An international cross-sectional study in 391 intensive care units. Crit Care 2010; 14:R185
5. Perel P, Roberts I: Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev 2011; 3:CD000567
6. Finfer S, Bellomo R, Boyce N, et al; SAFE Study Investigators: A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004; 350:2247-2256
7. Kastrup M, Markewitz A, Spies C, et al: Current practice of hemodynamic monitoring and vasopressor and inotropic therapy in postoperative cardiac surgery patients in Germany: Results from a postal survey. Acta Anaesthesiol Scand 2007; 51:347-358
8. Ziporyn T: The Food and Drug Administration: How those regulations came to be. JAMA 1985; 254:2037-2049
9. Dart AB, Mutter TC, Ruth CA, et al: Hydroxyethyl starch (HES) versus other fluid therapies: Effects on kidney function. Cochrane Database Syst Rev 2010; 1:CD007594
10. Zarychanski R, Turgeon AF, Fergusson DA, et al: Renal outcomes and mortality following hydroxyethyl starch resuscitation of critically ill patients: Systematic review and meta-analysis of randomized trials: ATTENTION: The analysis and conclusions of this article are being revised by the authors. This is due to the journal Anesthesia and Analgesia's retraction of a paper by Dr. Joachim Boldt, an author in seven of the studies analyzed in this review. As such, the editors of Open Medicine recommend interpreting this review with extreme caution until Zarychanski et al. publish a new analysis and interpretation in Open Medicine. For more information, see Anesthesia and Analgesia's press release. Open Med 2009; 3:e196-e209
11. Zarychanski R, Abou-Setta AM, Turgeon AF, et al: Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation: A systematic review and meta-analysis. JAMA 2013; 309:678-688
12. Westphal M, James MF, Kozek-Langenecker S, et al: Hydroxyethyl starches: Different products-Different effects. Anesthesiology 2009; 111:187-202
13. FLUIDS study investigators for the Scandinavian Critical Care Trials Group: Preferences for colloid use in Scandinavian intensive care units. Acta Anaesthesiol Scand 2008; 52:750-758
14. Liu FC, Liao CH, Chang YW, et al: Hydroxyethyl starch interferes with human blood ex vivo coagulation, platelet function and sedimentation. Acta Anaesthesiol Taiwan 2009; 47:71-78
15. Hartog CS, Kohl M, Reinhart K: A systematic review of third-generation hydroxyethyl starch (HES 130/0.4) in resuscitation: Safety not adequately addressed. Anesth Analg 2011; 112:635-645
16. Gattas DJ, Dan A, Myburgh J, et al; CHEST Management Committee: Fluid resuscitation with 6% hydroxyethyl starch (130/0.4) in acutely ill patients: An updated systematic review and meta-analysis. Anesth Analg 2012; 114:159-169
17. Thomas-Rueddel DO, Vlasakov V, Reinhart K, et al: Safety of gelatin for volume resuscitation-A systematic review and meta-analysis. Intensive Care Med 2012; 38:1134-1142
18. Reinhart K, Perner A, Sprung CL, et al; European Society of Intensive Care Medicine: Consensus statement of the ESICM task force on colloid volume therapy in critically ill patients. Intensive Care Med 2012; 38:368-383
19. Myburgh JA, Finfer S, Bellomo R, et al; CHEST Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group: Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012; 367:1901-1911
20. Perner A, Haase N, Guttormsen AB, et al; 6S Trial Group; Scandinavian Critical Care Trials Group: Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med 2012; 367:124-134
21. Brunkhorst FM, Engel C, Bloos F, et al; German Competence Network Sepsis (SepNet): Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008; 358:125-139
22. Schabinski F, Oishi J, Tuche F, et al: Effects of a predominantly hydroxyethyl starch (HES)-based and a predominantly non HES-based fluid therapy on renal function in surgical ICU patients. Intensive Care Med 2009; 35:1539-1547
23. Bayer O, Reinhart K, Sakr Y, et al: Renal effects of synthetic colloids and crystalloids in patients with severe sepsis: A prospective sequential comparison. Crit Care Med 2011; 39:1335-1342
24. Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee: A comparison of the RIFLE and AKIN criteria for acute kidney injury in critically ill patients. Nephrol Dial Transplant 2008; 23:1569-1574
25. Vincent JL, Moreno R, Takala J, et al: The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996; 22:707-710
26. D'Agostino R, Lang W, Walkup M, et al: Examining the impact of missing data on propensity score estimation in determining the effectiveness of self-monitoring of blood glucose (SMBG). Health Serv Outcomes Res Methodol 2001; 2:291-315
27. Wijeysundera DN, Karkouti K, Dupuis JY, et al: Derivation and validation of a simplified predictive index for renal replacement therapy after cardiac surgery. JAMA 2007; 297:1801-1809
28. Le Gall JR, Lemeshow S, Saulnier F: A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 1993; 270:2957-2963
29. Schortgen F, Lacherade JC, Bruneel F, et al: Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: A multicentre randomised study. Lancet 2001; 357:911-916
30. Schortgen F, Girou E, Deye N, et al; CRYCO Study Group: The risk associated with hyperoncotic colloids in patients with shock. Intensive Care Med 2008; 34:2157-2168
31. Rioux JP, Lessard M, De Bortoli B, et al: Pentastarch 10% (250 kDa/0.45) is an independent risk factor of acute kidney injury following cardiac surgery. Crit Care Med 2009; 37:1293-1298
32. Wiedermann CJ, Kaneider NC: A meta-analysis of controlled trials of recombinant human activated protein C therapy in patients with sepsis. BMC Emerg Med 2005; 5:7
33. Kief H, Engelbart K, Arnold G, et al: [Vacuolar reabsorption of native and digested gelatin (so-called osmotic nephrosis)]. Virchows Arch B Cell Pathol 1968; 1:240-250
34. Dickenmann M, Oettl T, Mihatsch MJ: Osmotic nephrosis: Acute kidney injury with accumulation of proximal tubular lysosomes due to administration of exogenous solutes. Am J Kidney Dis 2008; 51:491-503
35. Schick MA, Isbary TJ, Schlegel N, et al: The impact of crystalloid and colloid infusion on the kidney in rodent sepsis. Intensive Care Med 2010; 36:541-548
36. Hüter L, Simon TP, Weinmann L, et al: Hydroxyethylstarch impairs renal function and induces interstitial proliferation, macrophage infiltration and tubular damage in an isolated renal perfusion model. Crit Care 2009; 13:R23
37. Bellmann R, Feistritzer C, Wiedermann CJ: Effect of molecular weight and substitution on tissue uptake of hydroxyethyl starch: A meta-analysis of clinical studies. Clin Pharmacokinet 2012; 51:225-236
38. Groeneveld AB, Navickis RJ, Wilkes MM: Update on the comparative safety of colloids: A systematic review of clinical studies. Ann Surg 2011; 253:470-483
39. Auwerda JJ, Wilson JH, Sonneveld P: Foamy macrophage syndrome due to hydroxyethyl starch replacement: A severe side effect in plasmapheresis. Ann Intern Med 2002; 137:1013-1014
40. Schramko A, Suojaranta-Ylinen R, Kuitunen A, et al: Hydroxyethylstarch and gelatin solutions impair blood coagulation after cardiac surgery: A prospective randomized trial. Br J Anaesth 2010; 104:691-697
41. Department of Health and Human Services: Food and Drug Administration, 21 CFR Part 216 [Docket No. 98N-0655] list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. In: Federal Register (Volume 63), 1998, pp 54082-54089. Available at: http://www.fda.gov/ohrms/ dockets/98fr/100898b.txt. Accessed November 30, 2010
42. Haynes GR, Havidich JE, Payne KJ: Why the Food and Drug Administration changed the warning label for hetastarch. Anesthesiology 2004; 101:560-561
43. Lamke LO, Liljedahl SO: Plasma volume changes after infusion of various plasma expanders. Resuscitation 1976; 5:93-102
44. Guidet B, Martinet O, Boulain T et al: Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Crit Care 2012; 16:R94
45. Levick JR, Michel CC: Microvascular fluid exchange and the revised Starling principle. Cardiovasc Res 2010; 87:198-210
46. Wills BA, Nguyen MD, Ha TL, et al: Comparison of three fluid solutions for resuscitation in dengue shock syndrome. N Engl J Med 2005; 353:877-889
47. Levy B, Perez P, Perny J, et al: 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; 39:450-455
48. Van Der Linden P, James M, Mythen M, et al: Safety of modern starches used during surgery. Anesth Analg 2013; 116:35-48
49. Gattas DJ, Dan A, Myburgh J, et al; CHEST Management Committee: Fluid resuscitation with 6% hydroxyethyl starch (130/0.4 and 130/0.42) in acutely ill patients: Systematic review of effects on mortality and treatment with renal replacement therapy. Intensive Care Med 2013; 39:558-568
50. Wiedermann CJ, Joannidis M: Increased mortality after infusion of "modern" hydroxyethyl starch. Swiss Med Wkly 2013; 143:w13747