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Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.
The body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:
How do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?
There will be 4 different groups:
Cardiopulmonary bypass (CBP) with a heart-lung machine is mandatory for a vast majority of cardiac surgeries. Briefly the disposables in a CPB circuit consists of a reservoir, an oxygenator and tubings.
The role of CPB can be summarized as follows:
Heart-lung machine provides even the following:
Before connecting the CPB circuit to the patient's circulation it needs to be deaired. This is achieved by priming, i.e. filling the circuit with a liquid solution. The 2024 EACTS (European Association for Cardio-Thoracic Surgery)/EACTA (European Association of Cardiothoracic Anaesthesiology)/EBCP (European Board of Cardiovascular Perfusin) Guidelines on CPB in adult cardiac surgery point out that despite a wealth of studies, no consensus has been reached on the optimal composition of the priming solution. According to recent surveys, balanced crystalloids are the preferred priming solution, but there are no recommendations of the composition in the solution. The standard prime solution at our institution consists of Ringer Acetate which is a common crystalloid fluid in Sweden used intravenously for fluid and volume loss. Due to its composition, i.e. lower pH and sodium and higher chloride concentrations than the human blood, it is sometimes necessary to add electrolytes and other components to the circuit either in advance or after initiation of CPB. Previous studies have investigated various prime compositions and plasma osmolality. The crystalloid priming fluid used in these studies contained mannitol, which has a high osmolality. A former study from our group showed a significant decrease in blood sodium with a mannitol-containing prime, but no effects on plasma osmolality. Highly osmolar priming solution has further been studied, also containing mannitol, and found a steep rise in plasma osmolality. These studies used priming fluids with an addition of 80 mmol NaCl and 160 mmol NaCl, respectively. Plasmalyte is a newer crystalloid solution with a composition of sodium and chloride more similar to human plasma which could be of advantage. Plasmalyte is used for CPB priming in some cardiac centers. Studies on Plasmalyte as a priming solution have shown less metabolic acidosis compared to Ringer Lactate. However, it has not been used in our institution for this purpose and there are no studies comparing Plasmalyte with Ringer Acetate. The literature search has further not found any studies investigating non-mannitol CPB priming solutions with differing additions of NaCl. There is a need to fill this knowledge gap to proceed in developing of the optimal priming solution, tailored to variouse preexisting diseases or conditions.
Scientific questions The overall aim of the project is to investigate if clinical outcome after cardiac surgery can be improved by optimizing the priming solution.
The sub-projects will answer the questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ringer's Acetate 80 | Active Comparator | Ringer's Acetate 1100 ml with addition of 80 mmol NaCl |
|
| Plasmalyte | Active Comparator | Plasmalyte 1100 ml, no addition |
|
| Ringer's Acetate no add | Active Comparator | Ringer's Acetate 1100 ml, no addition |
|
| Ringer's Acetate 160 | Active Comparator | Ringer's Acetate with addition of 160 mmol NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer's Acetate 80 | Diagnostic Test | Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 80 mmol NaCl |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acid Base Balance | This study uses blood samples that are taken at predefined timepoints | Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative. |
| Sodium concentration | This study uses blood samples that are taken at predefined timepoints | Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3. |
| Osmolality | This study uses blood samples that are taken at predefined timepoints | Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 15 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Chloride, magnesium -and potassium concentrations | This study uses blood samples that are taken at predefined timepoints | Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Snejana Hyllén, PhD | Contact | +46 763131231 | snejana.hyllen@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Snejana Hyllén, Phd,MD | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University hospital | Recruiting | Lund | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33938829 | Background | Surabhi S, Kumar M. Comparison of ringer's lactate and plasmalyt-a as cardiopulmonary bypass prime for bypass associated acidosis in valve replacement surgeries. Ann Card Anaesth. 2021 Jan-Mar;24(1):36-41. doi: 10.4103/aca.ACA_104_19. | |
| 31287556 | Background | Ljunggren M, Skold A, Dardashti A, Hyllen S. The use of mannitol in cardiopulmonary bypass prime solution-Prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2019 Nov;63(10):1298-1305. doi: 10.1111/aas.13445. Epub 2019 Jul 29. |
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Anonymized participant data can be made available on request.
Anonymized data will be available November 2026 and stored for 10 years.
Requests must be from studies with appropriate ethics approval.
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| Plasmalyte | Diagnostic Test | Cardiopulmonary bypass circuit will be primed with Plasmalyte 1100 ml, no addition. |
|
| Ringer's Acetate no add | Diagnostic Test | Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml no addition |
|
| Ringer's Acetate 160 | Diagnostic Test | Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 160 mmol NaCl |
|
| Urine output | Production of urine will be studied during cardiac operation and post operative | Measurements of urine output will be registered during cardiac surgery and 24 hours post operative. |
| Kidney function | Creatinine-and urea concentration, glomerular filtration rate | Blood samples will be collected pre operative - the day before surgery or in morning the same day, 1 hour post operative, day 1 and day 4 post operative, and at month 3. |
| Neurological outcome | S-100, a prognostic biomarker used for assessing brain injury | Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative. |
| 30114960 | Background | Malmqvist G, Claesson Lingehall H, Appelblad M, Svenmarker S. Cardiopulmonary bypass prime composition: beyond crystalloids versus colloids. Perfusion. 2019 Mar;34(2):130-135. doi: 10.1177/0267659118793249. Epub 2018 Aug 16. |
| 39949326 | Background | Wahba A, Kunst G, De Somer F, Agerup Kildahl H, Milne B, Kjellberg G, Bauer A, Beyersdorf F, Berg Ravn H, Debeuckelaere G, Erdoes G, Haumann RG, Gudbjartsson T, Merkle F, Pacini D, Paternoster G, Onorati F, Ranucci M, Ristic N, Vives M, Milojevic M; EACTS/EACTAIC/EBCP Scientific Document Group. 2024 EACTS/EACTAIC/EBCP Guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2025 Feb 4;67(2):ezae354. doi: 10.1093/ejcts/ezae354. No abstract available. |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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