Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary
Carmen A Pfortmueller1, Anna S Messmer2, Benjamin Hess2
1Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland. Carmen.Pfortmueller@insel.ch.
Insights
This study investigated hypertonic saline (HS) for fluid resuscitation in cardiac surgery patients. HS may reduce total fluid volume administered and postoperative weight gain compared to normal saline (NS).
Area of Science:
- Critical Care Medicine
- Cardiovascular Surgery
- Nephrology
Background:
- Managing cardiac surgery patients requires complex fluid and vasopressor therapy.
- Positive fluid balance negatively impacts postoperative outcomes.
- The efficacy of buffered crystalloid solutions remains debated; hypertonic saline (HS) shows promise in preliminary studies for reducing fluid balance and weight gain in critically ill patients.
Purpose of the Study:
- To assess if fluid resuscitation with hypertonic saline (HS) in cardiac surgery patients leads to a lower total fluid volume administered.
- To test the hypothesis that HS reduces total infused fluids and postoperative weight gain compared to normal saline (NS).
Main Methods:
- A prospective, double-blind, randomized controlled trial involving 96 patients undergoing elective cardiac surgery.
- Patients received either HS (7.3% NaCl) or NS (0.9% NaCl) (5 ml/kg ideal body weight) in the intensive care unit (ICU).
- Data collected included blood/urine parameters, renal blood flow via ultrasonography, total body water, and 90-day follow-up.
Main Results:
- The primary endpoint is the cumulative fluid volume administered during ICU stay.
- Secondary endpoints include postoperative weight gain and changes in renal, cardiac, inflammatory, acid-base, and electrolyte parameters.
- Renal blood flow and total body water changes will also be assessed.
Conclusions:
- This preliminary study aims to provide further data on the use of HS in critically ill cardiac surgery patients.
- The findings will help determine if HS is a viable alternative to NS for fluid management in this population.
- The study hypothesizes reduced fluid administration and weight gain with HS.
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.
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