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Clinical Trials/NCT03302286
NCT03302286
Completed
Not Applicable

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

Region Skane1 site in 1 country110 target enrollmentOctober 1, 2017
ConditionsCardiac Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Region Skane
Enrollment
110
Locations
1
Primary Endpoint
osmolality
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
October 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Snejana Hyllén

MD

Region Skane

Eligibility Criteria

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

Outcomes

Primary Outcomes

osmolality

Time Frame: 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 Outcomes

  • urine outcome(Measurements will be taken during first 24 hours following cardiac surgery)

Study Sites (1)

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