Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial

Carmen A Pfortmueller, Anna S Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes, Markus M Luedi, Stephan M Jakob, Lars Englberger, Joerg C Schefold, Carmen A Pfortmueller, Anna S Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes, Markus M Luedi, Stephan M Jakob, Lars Englberger, Joerg C Schefold

Abstract

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.

Keywords: Cardiac surgery; Cardiosurgery; Critical illness; Fluid balance; Fluid resuscitation; Hypertonic saline; ICU; Ischaemic heart disease; Normal saline; Valvular heart disease.

Conflict of interest statement

The Department of Intensive Care Medicine (CAP, ASM, BH, LJ, SW, SMJ, JCS) has, or has had, research and/or development/consulting contracts with (full disclosure) Orion Corporation, Abbott Nutrition International, B. Braun Medical AG, the Swiss Center for Electronics and Microtechnology (CSEM SA), Edwards Lifesciences Services GmbH/SA, Kenta Biotech Ltd., Maquet Critical Care AB, Omnicare Clinical Research AG, and Nestlé. Educational grants were received from Fresenius Kabi, GlaxoSmithKline (GSK), Merck Sharp & Dohme (MSD), Lilly, Baxter, Astellas, AstraZeneca, B. Braun Medical AG, CSL Behring, Maquet, Novartis, Covidien, Nycomed, Pierre Fabre Pharma (Roba Pharma), Pfizer, and Orion Pharma. No personal financial gains resulted from the respective development/consulting contracts and/or educational grants. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure indicating visits and study-specific assessments

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