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

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

[img]
Preview
Text
2019 - Pfortmüller - Trials - PMID 31200756 .pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (755kB) | Preview

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.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic and Policlinic for Anaesthesiology and Pain Therapy
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Pfortmüller, Carmen; Messmer, Anna Sarah; Reineke, David Christian; Jakob, Laura Valeria; Wenger, Stefanie; Waskowski, Jan; Zürcher, Patrick; Stöhr, Frederik; Erdös, Gabor; Lüdi, Markus; Jakob, Stephan; Englberger, Lars and Schefold, Jörg Christian

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

26 Jul 2019 14:28

Last Modified:

22 Oct 2019 19:15

Publisher DOI:

10.1186/s13063-019-3420-6

PubMed ID:

31200756

Uncontrolled Keywords:

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

BORIS DOI:

10.7892/boris.131489

URI:

https://boris.unibe.ch/id/eprint/131489

Actions (login required)

Edit item Edit item
Provide Feedback