Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial
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 di...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3420-6 |
| _version_ | 1818267383664476160 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Carmen A. Pfortmueller |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T20:21:44Z |
| format | Article |
| id | doaj.art-918156bc66384a92905ecda212642bab |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T20:21:44Z |
| publishDate | 2019-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-918156bc66384a92905ecda212642bab2022-12-22T00:13:15ZengBMCTrials1745-62152019-06-012011910.1186/s13063-019-3420-6Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trialCarmen A. Pfortmueller0Anna S. Messmer1Benjamin Hess2David Reineke3Laura Jakob4Stefanie Wenger5Jan Waskowski6Patrick Zuercher7Frederik Stoehr8Gabor Erdoes9Markus M. Luedi10Stephan M. Jakob11Lars Englberger12Joerg C. Schefold13Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernDepartment of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of BernDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of BernAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3420-6Hypertonic salineNormal salineFluid resuscitationCardiac surgeryCardiosurgeryIschaemic heart disease |
| spellingShingle | 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 Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial Trials Hypertonic saline Normal saline Fluid resuscitation Cardiac surgery Cardiosurgery Ischaemic heart disease |
| title | Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial |
| title_full | Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial |
| title_fullStr | Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial |
| title_full_unstemmed | Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial |
| title_short | Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial |
| title_sort | hypertonic saline for fluid resuscitation after cardiac surgery heracles study protocol for a preliminary randomised controlled clinical trial |
| topic | Hypertonic saline Normal saline Fluid resuscitation Cardiac surgery Cardiosurgery Ischaemic heart disease |
| url | http://link.springer.com/article/10.1186/s13063-019-3420-6 |
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