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Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled
Wolfgang Buhre1, Óscar Díaz-Cambronero, Simon Schaefer
1From the Department of Anaesthesiology, Division of Vital Functions, University Medical Centre Utrecht Q4.2.300, Utrecht, The Netherlands (WB), Department Anesthesiology, Hospital Universitario y Politécnico la Fe Perioperative Medicine Research, Health Research Institute Hospital la Fe, Valencia, Spain, Faculty of Medicine, Department of Surgery, University of Valencia, Spain (ÓD-C), LMU Klinikum, Ludwig Maximilians-University München, München, Universitätsmedizin Oldenburg, Universitätsklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Carl von Ossietzky Universität Oldenburg und Klinikum Oldenburg, Oldenburg, Germany (SS), Department of Anaesthesia and Intensive Care, Oblastni nemocnice Kolin, a.s, Czech Republic (MN), Department of Anesthesiology and Intensive Care, Hospital IMED Valencia, Valencia, Spain (MSD), Jessa Hospital, Hasselt University, Hasselt, Belgium (BS), Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Spain (AR-P), Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Dresden (TR), Universitätsmedizin Oldenburg, Universitätsklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Carl von Ossietzky Universität Oldenburg und Klinikum Oldenburg, Oldenburg, Germany (GR), Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, Paris, Université Paris Cité, INSERM UMR-S1140 "Innovations Thérapeutiques en Hémostase", Paris, France (BC), University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG), Maastricht University Medical Center+, Maastricht, the Netherlands (GK), Service d'Anesthésie-Réanimation Saint Eloi, Centre Hospitalier Universitaire de Montpellier, Université, Montpellier, France (SJ), Maastricht University Medical Center+, Maastricht, the Netherlands (DdK), University of Valencia, Valencia, Spain (JB), Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Dresden, Germany, Department of Intensive Care and Resuscitation, Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA (MGdA), University Hospital Centre Zagreb, Zagreb, Croatia (RB), Department of Anaesthesiology and Intensive Care Medicine, Münster University Hospital, Münster, Germany (TS), Anesthesiology Department, Hospital Clínic de Barcelona, Barcelona, Spain (CFO), Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Anesthesia and Intensive Care Department, 5th Military Hospital, Krakow, Poland (WS), Department of Anaesthesia and Intensive Care, Fundeni Clinical Institute, Bucharest, Romania (DT), University Hospital Motol, Prague, Czech Republic (TV), University Hospital Center Sestre Milosrdnice, Zagreb, Croatia (ZG), Department of Anesthesiology, Hospital Universitario y Politécnico la Fe, Perioperative Medicine Research, Health Research Institute Hospital la Fe, Faculty of Medicine, Department of Surgery, University of Valencia (MPA-N), Department Anesthesiology, Hospital Universitario y Politécnico la Fe, Perioperative Medicine Research, Health Research Institute Hospital la Fe, Faculty of Mathematical Sciences, University of Valencia, Valencia, Spain (GM), LMU Klinikum, Ludwig Maximilians-University München, München, Germany (ST), Department Anesthesiology. Hospital Universitario y Politécnico la Fe, Perioperative Medicine Research, Health Research Institute Hospital la Fe, Valencia, Spain (NG-G), Jessa Hospital, Hasselt, Belgium, Hasselt University, Hasselt, Belgium (JV), Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, Paris, Université Paris Cité, INSERM UMR-S1140 "Innovations Thérapeutiques en Hémostase", Paris, France (DZ), Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Dresden (JW), Medical Scientific Affairs (SS), Medical Scientific Affairs, Hospital Care Division, B. Braun Melsungen AG, Melsungen (SR), BU Pharma & Nutrition, Medical Scientific Affairs, Safety in Clinical Trials & Data Management (CG), BU Pharma & Nutrition, Medical Scientific Affairs, Clinical Operations & Medical Writing (MH), BU Pharma & Nutrition, Global Regulatory Affairs, Regulatory Writing (CJ), BU Pharma & Nutrition, Medical Scientific Affairs, Clinical Operations & Medical Writing, Fresenius Kabi Deutschland GmbH Bad Homburg, Germany (UN), Center for Outcomes Research and Department of Anesthesiology, UTHealth, Houston, Texas, USA (DIS), and BU Pharma & Nutrition, Medical Scientific Affairs, Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany (MW).
Background:
Hydroxyethyl starch (HES) is often used for maintaining vascular volume during major surgery. Long-term high-dose HES in septic patients promotes renal injury, whereas meta-analyses of current HES products in surgical patients do not show such effects.
Objective:
We studied if the peri-operative use of HES is noninferior to crystalloids in terms of acute kidney injury. Secondary outcome was the noninferiority of HES on worsening of renal injury and/or the incidence of a composite endpoint of major complications and mortality until postoperative day 90.
Design:
Randomised double-blind trial in patients undergoing elective abdominal surgery with expected blood loss at least 500 ml.
Setting:
Multicentre trial at 53 study sites in 10 European countries.
Patients:
One thousand nine hundred and eighty-five (HES 977, crystalloid-only 981) patients aged 40 to 85 years with ASA status II-III.
Intervention:
Either 6% HES 130/0.4 or a crystalloid solution. Dosing was guided by mean arterial pressure and/or routine haemodynamic variables.
Main Outcome Measure:
Change from pre-operative to lowest cystatin C-based eGFR during the first 3 postoperative days. Key secondary outcome was a composite endpoint of mortality and major postoperative complications after 90 days.
Results:
Mean change in eGFR from baseline to minimum was -3.4 ± 17.7 ml min -1 1.73 m -2 in HES patients and -1.0 ± 17.1 ml min -1 1.73 m -2 in crystalloid-only patients ( P < 0.001 for noninferiority). The key secondary endpoint occurred in 35% of patients in each group. There were no clinically relevant differences in any safety endpoint including 90-day renal function. Any cause mortality-difference until the end of 1-year follow-up was not significantly different (8.6% in HES and 10.1% in crystalloid patients).
Conclusion:
Peri-operative use of HES was noninferior to crystalloids in short-term renal function or a composite of mortality and major complications at 90 days. PHOENICS provides robust evidence that peri-operative in-label use of HES is well tolerated.
Trial Registration And Funding:
EudraCT no. 2016-002162-30, clinicaltrials.gov ID NCT03278548.
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