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/31287556/Actively Recruiting
Led by Region Skane · Updated on 2025-12-05
80
Participants Needed
1
Research Sites
6 weeks
Total Duration
This research investigates how different priming solutions used in the heart-lung machine affect the bodys 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 Ringers Acetate alone, Ringers Acetate with 80 mmol sodium chloride, Ringers 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 bodys 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
Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery
S
Snejana Hyllén, PhD
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Region Skane
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/33938829/Region Skane
Lead Sponsor