Comparison of ringer's lactate and plasmalyt-a as cardiopulmonary bypass prime for bypass associated acidosis in valve replacement surgeries.
Sandill Surabhi, Meenakshi Kumar
https://pubmed.ncbi.nlm.nih.gov/33938829Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07267546
Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)
Led by Region Skane · Updated on 2025-12-05
80
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates how different priming solutions used in the heart-lung machine affect the body's acid-base balance, electrolyte levels, and clinical outcomes during cardiac surgery. The study focuses on patients undergoing coronary artery bypass graft or aortic valve replacement surgery, aiming to fill knowledge gaps about optimal priming fluid composition for better patient care and safety. Participants are randomly assigned to one of four groups receiving different priming solutions: Ringer's Acetate alone, Ringer's Acetate with 80 mmol sodium chloride, Ringer's Acetate with 160 mmol sodium chloride, or Plasmalyte alone. Each solution is used to fill the heart-lung machine circuit with 1100 mL before connecting to the patient. This approach helps compare how these fluids influence the body's chemical balance during surgery. Throughout the study, blood samples are collected at various times before, during, and after surgery to measure acid-base balance, sodium levels, osmolality, and other electrolytes. Urine output and hydration status are monitored until the first postoperative day. Additional kidney function and neurological assessments are performed up to three months after surgery. This comprehensive monitoring helps researchers evaluate the impact of each priming solution on patient health and recovery.
CONDITIONS
Brief 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
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
You will not qualify if you...
- Subnormal heart function (ejection fraction <45%) without signs of heart failure (edema)
- Body weight less than 60 kg or greater than 120 kg
- Preoperative hemoglobin less than 120 g/L
- Subnormal kidney function (glomerular filtration rate <30 ml/min)
- Blood sodium outside the normal range (135-145 mmol/L)
- Need for acute surgery
- Aortic valve replacement due to aortic valve insufficiency
- Changes in operating method or addition of intraoperative procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and up to 24 hours post operative
Participants undergo cardiac surgery with the heart-lung machine primed with one of the study solutions. Various blood measurements and urine output are taken during and immediately after surgery to assess acid-base balance, electrolyte composition, and kidney function.
1 surgery day visit and monitoring during 24 hours post operative
Post-operative Follow-up
Duration - Up to 4 days post operative with additional assessment at 3 months
Participants have follow-up assessments to monitor acid-base balance, electrolyte levels, kidney function, and neurological outcome after surgery.
Visits at 1 hour, day 1, day 4 post operative and 1 visit at 3 months
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
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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Published Research Related To This Trial
The use of mannitol in cardiopulmonary bypass prime solution-Prospective randomized double-blind clinical trial.
Magnus Ljunggren, Andreas Sköld, Alain Dardashti...
https://pubmed.ncbi.nlm.nih.gov/31287556Cardiopulmonary bypass prime composition: beyond crystalloids versus colloids.
Gunnar Malmqvist, Helena Claesson Lingehall, Micael Appelblad...
https://pubmed.ncbi.nlm.nih.gov/301149602024 EACTS/EACTAIC/EBCP Guidelines on cardiopulmonary bypass in adult cardiac surgery.
Alexander Wahba, Gudrun Kunst, Filip De Somer...
https://pubmed.ncbi.nlm.nih.gov/39949326