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

Region Skane

Status: Completed

Conditions: Cardiac Surgery

Treatments: Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol; Diagnostic Test: Heart-lung machine primining solution which includes Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT03302286

2017/422

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Mannitol Prime

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Heart-lung machine primining solution which includes Mannitol

NonMannitol Prime

Active Comparator group

Description:

This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.

Treatment:

Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol