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SHR Neuro Cancer Cardio Lipid Metab Microb
Buhre, W; Díaz-Cambronero, Ó; Schaefer, S; Novacek, M; Domingo, MS; Stessel, B; Rodríguez-Pérez, A; Richter, T; Rohe, G; Cholley, B; Gruenewald, M; Kuiper, G; Jaber, S; de, Korte, D; Belda, J; de, Abreu, MG; Baronica, R; Scheeren, T; Ferrando-Ortolá, C; Szczeklik, W; Tomescu, D; Vyzamal, T; Gavranovic, Z; Argente-Navarro, MP; Mazzinari, G; Thaler, S; García-Gregorio, N; Vandenbrande, J; Zlotnik, D; Wittenstein, J; Schmier, S; Rohn, S; Glasmacher, C; Holler, M; Jungheinrich, C; Niess, U; Sessler, DI; Westphal, M; Alberola, MJ; Aldecoa, C; Montero, BA; Baronica, R; Becerra-Bolaños, Á; Bornemann-Cimenti, H; Boselli, E; Bruno, L; Callebaut, I; Constantin, JM; Cordula, A; Cox, B; De, Jong, A; Depays, F; Diekmann, M; Diers, A; Dirzu, DS; Droc, G; Velez, ME; El, Amine, Y; Felipe, M; Gabriel, P; García, Del, Valle, S; Vargas, LG; Garner, M; Garutti, I; Geebelen, L; Godier, A; Goss, S; Grintescu, I; Groene, P; Grote, T; Gunnar, E; Hollmann, MW; Jankovic, R; Johannessen, MV; Kahn, D; Kaufmann, T; Kezar, A; Klimscha, W; Kluzik, A; Krofak, S; Krzych, Ł; Kudlinski, B; Lamrani, J; Lasocki, S; Lebuffe, G; Lennartz, S; Lewandowski, P; Marchesi, C; Castro, NM; Martin-Pacetti, MA; Matejka, V; Molina, I; Moreno, V; Müller, C; Muñoz-Forner, E; Novackova, L; Ongenae, M; Ostmeier, N; Owczuk, R; Sarmiento-Trujillo, T; Scharffenberg, M; Scheiermann, P; Marín, NS; Silvius, Ioan, N; Smit-Fun, V; Soukup, J; Trebesius, N; Trujillo-Morales, H; Tyll, T; Lorenzo, MU; Valencia-Sola, L; Verdeguer, S; Verdonk, F; Montañes, MV; Vojnar, B; Wappler, F; Weiss, T; Welna, M; Wittmann, M.
Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial.
Eur J Anaesthesiol. 2026; 43(1): 1-10.
Doi: 10.1097/EJA.0000000000002307
PubMed
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- Bornemann-Cimenti Helmar
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- Abstract:
- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Hydroxyethyl Starch Derivatives - adverse effects, administration & dosage
- Middle Aged - administration & dosage
- Male - administration & dosage
- Female - administration & dosage
- Aged - administration & dosage
- Double-Blind Method - administration & dosage
- Adult - administration & dosage
- Aged, 80 and over - administration & dosage
- Crystalloid Solutions - administration & dosage
- Plasma Substitutes - adverse effects, administration & dosage
- Acute Kidney Injury - chemically induced, diagnosis, epidemiology, prevention & control
- Treatment Outcome - administration & dosage
- Postoperative Complications - epidemiology
- Elective Surgical Procedures - adverse effects