Cardiac Surgery
Conditions
Keywords
Heart-Lung Machine, Cardiopulmonary Bypass
Brief summary
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.
Interventions
DIAGNOSTIC_TESTHeart-lung machine primining solution which includes Mannitol
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.
DIAGNOSTIC_TESTHeart-lung machine primining solution which does not include Mannitol
This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| osmolality | Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass. | This study uses blood samples that are taken at predefined timepoints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urine outcome | Measurements will be taken during first 24 hours following cardiac surgery | Production of urine will be studed following cardiac operation |
Countries
Sweden
Outcome results
None listed