RecruitingNot ApplicableNCT07267546

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

Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)


Sponsor

Region Skane

Enrollment

80 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria8

  • 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),
  • Blood sodium outside normal range (135-145 mmol/l),
  • Need of acute surgery
  • AVR due to aortic valve insufficiency
  • Changes in operating method or addition of intraoperative procedures.

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Interventions

DIAGNOSTIC_TESTRinger's Acetate 80

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

DIAGNOSTIC_TESTPlasmalyte

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

DIAGNOSTIC_TESTRinger's Acetate no add

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

DIAGNOSTIC_TESTRinger's Acetate 160

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


Locations(1)

Skane University hospital

Lund, Sweden

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NCT07267546


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