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Completed

NCT Number: NCT03302286

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

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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thorax

Lund, Skåne County, 22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart-lung machine primining solution which includes Mannitol

Diagnostic Test

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

Diagnostic Test

This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.

Primary outcomes

  1. 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

  1. urine outcome

    Time frame: Measurements will be taken during first 24 hours following cardiac surgery

    Production of urine will be studed following cardiac operation

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: Prime

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2017
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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