Effects of hydroxyethyl starch in subgroups of patients with severe sepsis: Exploratory post-hoc analyses of a randomised trial

Intensive Care Medicine

Volumn 39, Issue 11, 2013, Pages 1963-1971

  Müller, Rasmus G ^a   Haase, Nicolai ^a   Wetterslev, Jorn ^a   Perner, Anders ^a  

^a Rigshospitalet   (Denmark)

Author keywords

Colloids; Hydroxyethyl starch; Resuscitation; Sepsis

Indexed keywords

HETASTARCH; HYPERTENSIVE AGENT; INOTROPIC AGENT; LACTIC ACID; RINGER ACETATE; STEROFUNDIN; TETRASPAN; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; COLLOID; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFECT; EXPLORATORY RESEARCH; HUMAN; HYPOTENSION; INTENSIVE CARE UNIT; LACTATE BLOOD LEVEL; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESUSCITATION; SEPSIS; SHOCK;

AGED; FEMALE; HOSPITAL MORTALITY; HUMANS; HYDROXYETHYL STARCH DERIVATIVES; INTENSIVE CARE UNITS; ISOTONIC SOLUTIONS; MALE; MIDDLE AGED; RESUSCITATION; SEPSIS; TREATMENT OUTCOME;

EID: 84885431033     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-013-3090-x     Document Type: Article

References (31)

1. Haase N, Perner A, Hennings LI, Siegemund M, Lauridsen B, Wetterslev M, Wetterslev J (2013) Hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin in patients with sepsis: Systematic review with meta-analysis and trial sequential analysis. BMJ 346:f839
2. Zarychanski R, Abou-Setta AM, Turgeon AF, Houston BL, McIntyre L, Marshall JC, Fergusson DA (2013) 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 309:678-688
3. Patel A, Waheed U, Brett SJ (2013) Randomised trials of 6% tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: Systematic review and meta-analysis. Intensive Care Med 39:811-822
4. Perel P, Roberts I, Ker K (2013) Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev 2:CD000567
5. Gattas DJ, Dan A, Myburgh J, Billot L, Lo S, Finfer S (2013) 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 39:558-568
6. Wiedermann CJ, Joannidis M (2013) Increased mortality after infusion of modern hydroxyethyl starch. Swiss Med Wkly 143:w13747
7. Antonelli M, Bonten M, Chastre J, Citerio G, Conti G, Curtis JR, De Backer D, Hedenstierna G, Joannidis M, Macrae D, Mancebo J, Maggiore SM, Mebazaa A, Preiser J-C, Rocco P, Timsit J-F, Wernerman J, Zhang H (2012) Year in review in intensive care medicine 2011. II. Cardiovascular, infections, pneumonia and sepsis, critical care organization and outcome, education, ultrasonography, metabolism and coagulation. Intensive Care Med 38:345-358
8. Antonelli M, Bonten M, Cecconi M, Chastre J, Citerio G, Conti G, Curtis JR, Hedenstierna G, Joannidis M, Macrae D, Maggiore SM, Mancebo J, Mebazaa A, Preiser J-C, Rocco P, Timsit J-F, Wernerman J, Zhang H (2013) Year in review in intensive care medicine 2012. II: Pneumonia and infection, sepsis, coagulation, hemodynamics, cardiovascular and microcirculation, critical care organization, imaging, ethics and legal issues. Intensive Care Med 39:345-364
9. European Medicines Agency (EMA) (2013) PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch. EMA/349341/2013. Available at: Http://www.ema.europa.eu/docs/en-GB/document- library/Press-release/2013/06/WC500144446.pdf. Accessed 17 Jun 2013
10. Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Moller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard A-L, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J (2012) Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med 367:124-134
11. Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McGuinness S, Rajbhandari D, Taylor CB, Webb SAR (2012) Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 367:1901-1911
12. Magder S (2012) Protocols, physiology, and trials of hydroxyethyl starch. N Engl J Med 367:1265-1267
13. Von Heymann C, Sander M, Spies CD (2012) Protocols, physiology, and trials of hydroxyethyl starch. N Engl J Med 367:1265-1266
14. Chappell D, Jacob M (2012) Protocols, physiology, and trials of hydroxyethyl starch. N Engl J Med 367:1266-1267
15. Wise R, Fourie C, Richards GA (2012) Protocols, physiology, and trials of hydroxyethyl starch. N Engl J Med 367:1266-1267
16. Ertmer C, Kampmeier T, Van Aken H (2013) Fluid therapy in critical illness: A special focus on indication, the use of hydroxyethyl starch and its different raw materials. Curr Opin Anaesthesiol 26:253-260
17. Schramko AA (2013) Removal of colloids: Evidence- or emotional-based medicine? Acta Anaesthesiol Scand 57(6):809
18. Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M (2001) Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 345:1368-1377
19. Van Der Linden P, James M, Mythen M, Weiskopf RB (2013) Safety of modern starches used during surgery. Anesth Analg 116:35-48
20. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent J-L, Moreno R (2013) Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med 39:165-228
21. Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut J-F, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent J-L (2008) Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med 34:17-60
22. Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J (2010) Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care 14:R185
23. Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bodker KD, Bådstolokken PM, Bendtsen A, Soe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bülow H-H, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schoidt O, Leivdal S, Berezowicz P, Pettilä V, Ruokonen E, Klepstad P, Karlsson S, Kaukonen M, Rutanen J, Karason S, Kjældgaard AL, Holst LB, Wernerman J (2011) Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S-Scandinavian Starch for Severe Sepsis/Septic Shock trial): Study protocol, design and rationale for a double-blinded, randomised clinical trial. Trials 12:24
24. Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H (2012) Assessment of hemodynamic efficacy and safety of 6% hydroxyethyl starch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Crit Care 16:R94
25. Lindroos ACB, Niiya T, Silvasti-Lundell M, Randell T, Hernesniemi J, Niemi TT (2013) Stroke volume-directed administration of hydroxyethyl starch or Ringer's acetate in sitting position during craniotomy. Acta Anaesthesiol Scand 57:729-736
26. Muller L, Jaber S, Molinari N, Favier L, Larché J, Motte G, Lazarovici S, Jacques L, Alonso S, Leone M, Constantin JM, Allaouchiche B, Suehs C, Lefrant J-Y (2012) Fluid management and risk factors for renal dysfunction in patients with severe sepsis and/or septic shock. Crit Care 16:R34
27. Finfer S, McEvoy S, Bellomo R, McArthur C, Myburgh J, Norton R (2011) Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis. Intensive Care Med 37:86-96
28. Meybohm P, Van Aken H, De Gasperi A, De Hert S, Della Rocca G, Girbes AR, Gombotz H, Guidet B, Hasibeder W, Hollmann MW, Ince C, Jacob M, Kranke P, Kozek-Langenecker S, Loer SA, Martin CD, Siegemund M, Wunder C, Zacharowski K (2013) Re-evaluating currently available data and suggestions for planning randomised controlled studies regarding the use of hydroxyethyl-starch in critically ill patients-a multidisciplinary statement. Crit Care (London) 17:R166
29. Hartog CS, Kohl M, Reinhart K (2011) A systematic review of third-generation hydroxyethyl starch (HES 130/0.4) in resuscitation: Safety not adequately addressed. Anesth Analg 112:635-645
30. Le Gall JR, Lemeshow S, Saulnier F (1993) A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 270:2957-2963
31. Vincent JL, de Mendonça A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S (1998) Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: Results of a multicenter, prospective study. Working group on sepsis-related problems of the European Society of Intensive Care Medicine. Crit Care Med 26:1793-1800