{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T23:48:38Z","timestamp":1793836118374,"version":"4.6.1"},"reference-count":44,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T00:00:00Z","timestamp":1753660800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"B. Braun Melsungen AG"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objective: Sepsis is a leading cause of death in noncoronary intensive care units (ICUs). Fluids for intravascular resuscitation include crystalloids and colloids. There is extensive clinical evidence on colloid use, but large trials comparing gelatine with crystalloid regimens in ICU and septic patients are lacking. This study aimed to determine whether early, protocol-driven volume resuscitation using a gelatine-based regimen achieves hemodynamic stability (HDS) more rapidly than a crystalloid-based regimen in septic patients. Methods: This prospective, controlled, randomised, double-blind, multinational phase IV study compared two parallel groups of septic patients receiving a gelatine-based regimen (Gelaspan\u00ae 4% and Sterofundin\u00ae ISO, B. Braun Melsungen AG each, at a 1:1 ratio) or a crystalloid regimen (Sterofundin\u00ae ISO). Primary endpoint was time to first HDS within 48 h after randomisation. Secondary endpoints included fluid overload, fluid balance, and patient outcomes. Results: 167 patients were randomised. HDS was achieved after 4.7 h in the gelatine group and after 5.8 h in the crystalloid group (p = 0.3716). The gelatine group had a more favourable fluid balance at 24 h (medians: 3463.00 mL vs. 4164.00 mL; p = 0.0395) and less fluid overload (medians: 4296.05 vs. 5218.75%; p = 0.0217). No differences were observed in serious adverse events or mortality. Conclusions: The study provided clinical evidence of balanced gelatine solution for volume resuscitation in septic patients, although it was terminated prematurely. The early and protocol-based administration of gelatine was safe and effective in the enrolled patient population. Time to HDS was not different between groups but the gelatine-based regimen led to better fluid balance and less fluid overload.<\/jats:p>","DOI":"10.3390\/jcm14155323","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T14:05:47Z","timestamp":1753711547000},"page":"5323","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and Safety of a Balanced Gelatine Solution for Fluid Resuscitation in Sepsis: A Prospective, Randomised, Controlled, Double-Blind Trial-GENIUS Trial"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0866-4234","authenticated-orcid":false,"given":"Gernot","family":"Marx","sequence":"first","affiliation":[{"name":"Department of Intensive Care and Intermediate Care, University Hospital RWTH Aachen, Pauwelsstra\u00dfe 30, 52074 Aachen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Benes","sequence":"additional","affiliation":[{"name":"Faculty of Medicine in Hradec Kralove, Charles University in Prague, University Hospital Hradec Kralove, Department of Anaesthesiology, Perioperative Medicine and Intensive Care, Masaryk Hospital, J.E. Purkinje University, 400 96 Usti nad Labem, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4859-4747","authenticated-orcid":false,"given":"Ricard","family":"Ferrer","sequence":"additional","affiliation":[{"name":"Servicio de Medicina Intensiva, Hospital Universitari Vall d\u2019Hebron, Passeig Vall d\u2019Hebron, 119-129, 08035 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1225-4214","authenticated-orcid":false,"given":"Dietmar","family":"Fries","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Critical Care Medicine, Medical University Innsbruck, Anichstra\u00dfe 35, 6020 Innsbruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Ehler","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany"},{"name":"Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Rostock, Schillingallee 35, 18057 Rostock, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolf","family":"Dembinski","sequence":"additional","affiliation":[{"name":"Department of Critical Care and Emergency Medicine, Klinikum Bremen-Mitte, St. J\u00fcrgen-Stra\u00dfe 1, 28177 Bremen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Rosenberger","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology and Intensive Care Medicine, University Hospital T\u00fcbingen, Hoppe-Seyler-Stra\u00dfe 3, 72076 T\u00fcbingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Zacharowski","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Intensive Care Medicine & Pain Therapy, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8876-3322","authenticated-orcid":false,"given":"Manuel","family":"Sanchez","sequence":"additional","affiliation":[{"name":"Hospital Universitario La Paz, Instituto de investigaci\u00f3n IdiPAZ, Servicio de Medicina Intensiva, Paseo de la Castellana, 261, 28046 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karim","family":"Asehnoune","sequence":"additional","affiliation":[{"name":"Service d\u2019Anesth\u00e9sie R\u00e9animation, Nantes Universit\u00e9, Centre Hospitalier Universitaire de Nantes, P\u00f4le Anaesth\u00e9sie R\u00e9animations, Service d\u2019Anesth\u00e9sie R\u00e9animation, Chirurgicale 1, Place Alexis Ricordeau, 44093 Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Bachmann-Mennenga","sequence":"additional","affiliation":[{"name":"Institute for Anaesthesiology, Intensive Care and Emergency Medicine, Johannes Wesling Hospital Minden, Hans-Nolte-Str. 1, 32429 Minden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carole","family":"Ichai","sequence":"additional","affiliation":[{"name":"Service de R\u00e9animation Polyvalente, IRCAN, Inserm U1081, CNRS UMR7284 et CHU de Nice, H\u00f4pital Pasteur 2, 30 Voie Romaine, CHU de Nice, 06000 Nice, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim-Philipp","family":"Simon","sequence":"additional","affiliation":[{"name":"Department of Intensive Care and Intermediate Care, University Hospital RWTH Aachen, Pauwelsstra\u00dfe 30, 52074 Aachen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,28]]},"reference":[{"key":"ref_1","first-page":"673","article-title":"Sepsis in the intensive care unit","volume":"30","author":"Bennett","year":"2012","journal-title":"Surgery"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"237","DOI":"10.3949\/ccjm.82gr.15001","article-title":"The surviving sepsis campaign: Where have we been and where are we going?","volume":"82","author":"Dellinger","year":"2015","journal-title":"Clevel. 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