How the heart-lung machine priming fluid affects blood chemistry during heart surgery
Official title: Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)
Run by Region Skane · NCT07267546 · Data updated 2026-11-12
This trial will test whether different priming fluids used to fill the heart-lung machine change acid-base balance, electrolytes, and osmolality in adults having isolated CABG or aortic valve replacement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 20, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT07267546 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older, weighing 60–120 kg, with preserved heart function (EF ≥45%), normal preoperative sodium and hemoglobin ≥120 g/L, and scheduled for isolated CABG or isolated AVR who give informed consent are ideal candidates.
✕Probably not a fit
Patients with reduced ejection fraction, severe kidney impairment (GFR <30 ml/min), abnormal sodium, low hemoglobin, very low or high body weight, urgent surgery, or those requiring additional intraoperative procedures are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults undergoing isolated coronary artery bypass grafting or aortic valve replacement at a single center will receive one of four cardiopulmonary bypass priming regimens. The CPB circuit is filled with about 1100 mL of fluid before connection, and the trial compares Ringer's acetate (with two different modifications) and Plasma-Lyte as priming solutions. Blood chemistry including acid-base parameters, electrolytes, and plasma osmolality will be sampled around the operative period to track immediate changes. Clinical outcomes and laboratory values will be compared between groups to determine which priming approach best preserves homeostasis.
Why it matters
Potential benefit: If successful, the results could guide choice of priming fluid to better preserve electrolyte and acid-base balance and potentially reduce perioperative complications.
How similar studies have gone: Balanced crystalloid versus other fluids for CPB priming and for broader perioperative care has been studied before with mixed results, so this is a focused comparison but not wholly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Skane University hospital
Lund, Sweden Recruiting
Study contacts
- Principal investigator: Snejana Hyllén, Phd,MD — Region Skane
- Study coordinator: Snejana Hyllén, PhD
- Email: snejana.hyllen@skane.se
- Phone: +46 763131231
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.