caa a22 4500 569310199 20200902041508.0 cr unu---uuuuu 190727e20190614xx s 000 0 eng (BORIS)oai:boris.unibe.ch:131489 610 ddc Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial [Elektronische Daten] [Carmen Pfortmüller, Anna S. Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zürcher, Frederik Stöhr, Gabor Erdös, Markus M. Lüdi, Stephan M. Jakob, Lars Englberger, Jörg C. Schefold] publishedVersion openAccess eu-repo BACKGROUND Intraoperative and postoperative management of cardiac surgery patients is complex, involving the application of differential vasopressors and volume therapy. It has been shown that a positive fluid balance has a major impact on postoperative outcome. Today, the advantages and disadvantages of buffered crystalloid solutes are a topic of controversy, with no consensus being reached so far. The use of hypertonic saline (HS) has shown promising results with respect to lower total fluid balance and postoperative weight gain in critically ill patients in preliminary studies. However, collection of more data on HS in critically ill patients seems warranted. This preliminary study aims to investigate whether fluid resuscitation using HS in patients following cardiac surgery results in less total fluid volume being administered. METHODS In a prospective double-blind randomised controlled clinical trial, we aim to recruit 96 patients undergoing elective cardiac surgery for ischaemic and/or valvular heart disease. After postoperative admission to the intensive care unit (ICU), patients will be randomly assigned to receive 5 ml/kg ideal body weight HS (7.3% NaCl) or normal saline (NS, 0.9% NaCl) infused within 60 min. Blood and urine samples will be collected preoperatively and postoperatively up to day 6 to assess changes in renal, cardiac, inflammatory, acid-base, and electrolyte parameters. Additionally, we will perform renal ultrasonography studies to assess renal blood flow before, during, and after infusion, and we will measure total body water using preoperative and postoperative body composition analysis (bioimpedance). Patients will be followed up for 90 days. DISCUSSION The key objective of this study is to assess the cumulative amount of fluid administered in the intervention (HS) group versus control (NS) group during the ICU stay. In this preliminary, prospective, randomised controlled clinical trial we will test the hypothesis that use of HS results in less total fluids infused and less postoperative weight gain when compared to the standard of intensive care in cardiac surgery patients. TRIAL REGISTRATION ClinicalTrials.gov, NCT03280745 . Registered on 12 September 2017. Pfortmüller Carmen joint author Messmer Anna S. joint author Hess Benjamin joint author Reineke David joint author Jakob Laura joint author Wenger Stefanie joint author Waskowski Jan joint author Zürcher Patrick joint author Stöhr Frederik joint author Erdös Gabor joint author Lüdi Markus M. joint author Jakob Stephan M. joint author Englberger Lars joint author Schefold Jörg C. joint author Trials 20(1), p. 357 Onlinezugriff via WWW text/html Pfortmüller, Carmen; Messmer, Anna S.; Hess, Benjamin; Reineke, David; Jakob, Laura; Wenger, Stefanie; Waskowski, Jan; Zürcher, Patrick; Stöhr, Frederik; Erdös, Gabor; Lüdi, Markus M.; Jakob, Stephan M.; Englberger, Lars; Schefold, Jörg C. (2019). Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial. Trials, 20(1), p. 357. BioMed Central 10.1186/s13063-019-3420-6 <http://dx.doi.org/10.1186/s13063-019-3420-6> BORIS BK010053 XK010053 XK010000 1 info:eu-repo/semantics/article boris PeerReviewed boris peerstatus BORIS BORIS BORIS info:eu-repo/semantics/article openAccess BORIS 856 42 Onlinezugriff via WWW text/html Pfortmüller, Carmen; Messmer, Anna S.; Hess, Benjamin; Reineke, David; Jakob, Laura; Wenger, Stefanie; Waskowski, Jan; Zürcher, Patrick; Stöhr, Frederik; Erdös, Gabor; Lüdi, Markus M.; Jakob, Stephan M.; Englberger, Lars; Schefold, Jörg C. (2019). Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial. Trials, 20(1), p. 357. BioMed Central 10.1186/s13063-019-3420-6 <http://dx.doi.org/10.1186/s13063-019-3420-6> BORIS 700 1- Pfortmüller Carmen joint author BORIS 700 1- Messmer Anna S. joint author BORIS 700 1- Hess Benjamin joint author BORIS 700 1- Reineke David joint author BORIS 700 1- Jakob Laura joint author BORIS 700 1- Wenger Stefanie joint author BORIS 700 1- Waskowski Jan joint author BORIS 700 1- Zürcher Patrick joint author BORIS 700 1- Stöhr Frederik joint author BORIS 700 1- Erdös Gabor joint author BORIS 700 1- Lüdi Markus M. joint author BORIS 700 1- Jakob Stephan M. joint author BORIS 700 1- Englberger Lars joint author BORIS 700 1- Schefold Jörg C. joint author BORIS 773 0- Trials 20(1), p. 357