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

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol; Diagnostic Test: Heart-lung machine primining solution which includes Mannitol

• Registration Number: NCT03302286
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-25
• Study Start: 2017-10-01
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NonMannitol Prime	Heart-lung machine primining solution which does not include Mannitol	This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.
Mannitol Prime	Heart-lung machine primining solution which includes Mannitol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
urine outcome	Measurements will be taken during first 24 hours following cardiac surgery	Production of urine will be studed following cardiac operation

Trial Locations

Locations (1)

Thorax; 🇸🇪 Lund, Skane, Sweden