Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Diagnostic Test: Heart-lung machine primining solution which includes Mannitol
* Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund Exclusion Criteria: heart failure with left ventricular ejection fraction below 50% small size (defined as bodyweight less than 50 kg) anaemia with haematocrit less than 24% patients with previous cardiac surgery patients who receive other fluids or more than 1000 ml additional Ringers's Acetate during cardiopulmonary bypass patients with peroperative complications including massive peroperative fluid transfusions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mannitol Prime<br>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. | Diagnostic Test: Heart-lung machine primining solution which includes Mannitol<br>* 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.<br>|
| Active Comparator: NonMannitol Prime<br>This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium. | Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol<br>* This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart-Lung Machine, Cardiopulmonary Bypass