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About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and total protein content. This hemodilution is an unavoidable consequence of the use of a heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and electrolytes is affected by the prime solution and can be maintained within normal limits. There are no clear recommendation regarding prime components and numerous prime solutions are in use worldwide.
The aim of this study is to investigate whether the use of mannitol in heart-lung machine prime has an effect on electrolytes levels and osmolality when compared with patients who receive no Mannitol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mannitol Prime | Active Comparator | This group will undergo cardiac surgery with heart-lung machine with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium. |
|
| NonMannitol Prime | Active Comparator | This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart-lung machine primining solution which includes Mannitol | Diagnostic Test | This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium. |
| Measure | Description | Time Frame |
|---|---|---|
| osmolality | This study uses blood samples that are taken at predefined timepoints. | Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass. |
| Measure | Description | Time Frame |
|---|---|---|
| urine outcome | Production of urine will be studed following cardiac operation | Measurements will be taken during first 24 hours following cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Snejana Hyllen, phd | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thorax | Lund | SkĂĄne County | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40411794 | Derived | Skold A, Dardashti A, Lindstedt S, Hyllen S. No benefit of adding mannitol to cardiopulmonary bypass priming solution assessing cystatin C. A randomized clinical trial. Perfusion. 2026 Mar;41(2):155-164. doi: 10.1177/02676591251344857. Epub 2025 May 24. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 3, 2026 | |
| Reset | Jan 20, 2026 |
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| Heart-lung machine primining solution which does not include Mannitol | Diagnostic Test | This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium. |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 3, 2026 | Jan 20, 2026 |