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

Cardiac Surgery Clinical Trial

— Prime  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302286
• Other study ID #: 2017/422
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Diagnostic Test:
• Heart-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.
• Heart-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.

Locations

Country	Name	City	State
Sweden	Thorax	Lund	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	urine outcome	Production of urine will be studed following cardiac operation	Measurements will be taken during first 24 hours following cardiac surgery