Trial reportEuropean journal of anaesthesiology2026
Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial.
Wolfgang Buhre, Óscar Díaz-Cambronero, Simon Schaefer, Martin Novacek, Marina Soro Domingo, Bjorn Stessel, Aurelio Rodríguez-Pérez, Torsten Richter, Georg Rohe, Bernard Cholley and 29 more
Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
Trial report in European journal of anaesthesiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03278548 (Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch), which is not on this map. Cited by 4 papers.
0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
TypeinterventionalSponsorFresenius KabiRan2017 to 2022Enrolled2,289ConditionsHypovolaemia Due to Acute Blood LossArmsVolulyte 6%, Ionolyte
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
39 authors.
Wolfgang BuhreFrom 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).ORCID 0000-0002-8296-9426
Óscar Díaz-Cambronero
Simon Schaefer
Martin Novacek
Marina Soro Domingo
Bjorn Stessel
Aurelio Rodríguez-Pérez
Torsten Richter
Georg Rohe
Bernard Cholley
Matthias Gruenewald
Gerhardus Kuiper
Samir Jaber
Dianne de Korte
Javier Belda
Marcelo Gama de Abreu
Robert Baronica
Thomas Scheeren
Carlos Ferrando-Ortolá
Wojciech Szczeklik
Dana Tomescu
Tomas Vyzamal
Zejka Gavranovic
María Pilar Argente-Navarro
Guido Mazzinari
Sarah Thaler
Nuria García-Gregorio
Jeroen Vandenbrande
Diane Zlotnik
Jakob Wittenstein
Sonja Schmier
Susanne Rohn
Christoph Glasmacher
Martin Holler
Cornelius Jungheinrich
Ulf Niess
Daniel I Sessler
Martin Westphal
New Collective Author
Funding
No grant is acknowledged in the PubMed record.
6 · The paper itself
Abstract
backgroundHydroxyethyl 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.
objectiveWe 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.
designRandomised double-blind trial in patients undergoing elective abdominal surgery with expected blood loss at least 500 ml.
settingMulticentre 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.
interventionEither 6% HES 130/0.4 or a crystalloid solution. Dosing was guided by mean arterial pressure and/or routine haemodynamic variables.
main outcome measureChange 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.
resultsMean 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).
conclusionPeri-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
fundingEudraCT no. 2016-002162-30, clinicaltrials.gov ID NCT03278548.
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Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial. · full record | OpenQuestion