Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.

The body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:

How do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?

There will be 4 different groups:

1. Ringer-Acetate, 1100 mL / no addition 2. Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl) 3. Ringer-Acetate, 1100 mL + 160 mmol NaCl 4. Plasmalyte, 1100 mL / no addition Blood samples will be taken before, during and after surgery, post operative day 1 and 4 to analyze acid-base balance, electrolytes, and plasma osmolality. Urine output and hydration status will also be collected until post operative day 1. After 3 months, a blood sample will be taken for analysis of electrolytes and kidney function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years and above

Undergoing coronary artery bypass graft (CABG) surgery as single surgery

Undergoing aortic valve replacement (AVR) as single surgery (AtriClip is allowed)

Given consent to participate, both verbal and written

Disqualifiers

Subnormal heart function (defined as an ejection fraction <45%), and no signs of heart failure (edema).

Body weight <60 kg or >120 kg

Preoperative hemoglobin <120 g/L,

Subnormal kidney function (defined as GFR <30 ml/min),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ringer's Acetate 80

    Diagnostic test

    Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 80 mmol NaCl

  • Plasmalyte

    Diagnostic test

    Cardiopulmonary bypass circuit will be primed with Plasmalyte 1100 ml, no addition.

  • Ringer's Acetate no add

    Diagnostic test

    Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml no addition

  • Ringer's Acetate 160

    Diagnostic test

    Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 160 mmol NaCl

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Ringer's Acetate 80Active comparator 1 intervention
Group B: PlasmalyteActive comparator 1 intervention
Group C: Ringer's Acetate no addActive comparator 1 intervention
Group D: Ringer's Acetate 160Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acid Base Balance

This study uses blood samples that are taken at predefined timepoints

Time frame
Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative.
2

Sodium concentration

This study uses blood samples that are taken at predefined timepoints

Time frame
Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
3

Osmolality

This study uses blood samples that are taken at predefined timepoints

Time frame
Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 15 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative

Secondary outcomes

1

Chloride, magnesium -and potassium concentrations

This study uses blood samples that are taken at predefined timepoints

Time frame
Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
2

Urine output

Production of urine will be studied during cardiac operation and post operative

Time frame
Measurements of urine output will be registered during cardiac surgery and 24 hours post operative.
3

Kidney function

Creatinine-and urea concentration, glomerular filtration rate

Time frame
Blood samples will be collected pre operative - the day before surgery or in morning the same day, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
4

Neurological outcome

S-100, a prognostic biomarker used for assessing brain injury

Time frame
Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative.

Other outcomes

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