Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07267546

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

Led by Region Skane · Updated on 2025-12-05

80

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Subnormal heart function defined as ejection fraction less than 45% with no signs of heart failure (edema)
  • Body weight less than 60 kg or more than 120 kg
  • Preoperative hemoglobin less than 120 g/L
  • Subnormal kidney function defined as GFR less than 30 ml/min
  • Blood sodium outside normal range (135-145 mmol/l)
  • Need for acute surgery
  • AVR due to aortic valve insufficiency
  • Changes in operating method or addition of intraoperative procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Skane University hospital

Lund, Sweden, 22185

Actively Recruiting

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Research Team

S

Snejana Hyllén, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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