Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial-the EASY-CS study.
Christophe Beyls, Nicolas Mollet, Louis Gibert...
https://pubmed.ncbi.nlm.nih.gov/41057198Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07077772
Evaluation of Natriuresis-guided Furosemide Dosing After Cardiac Surgery: A Randomized Open-label Trial
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-01-21
102
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Fluid overload is a common issue after cardiac surgery, leading to increased risks for patients. Researchers are evaluating whether using a urinary sodium sensor to guide furosemide dosing can improve fluid removal safely and effectively in patients who have undergone cardiac surgery with cardiopulmonary bypass. Participants receive intravenous furosemide starting at 20 mg, with doses adjusted every 6 hours. One group has doses guided by urinary sodium levels using the LAQUAtwin NA-11 device, while the other group has doses adjusted based on clinical evaluation. Urine output is closely monitored every 4 hours, and blood tests are done twice daily to track electrolytes and kidney function. If patients show signs of instability, detailed heart and hemodynamic assessments are performed. During the 48-hour study period after randomization, researchers measure total urine output and natriuresis, along with fluid balance and complications up to 30 days later. The trial monitors safety closely, including any contraindications to furosemide and corrective measures taken. This randomized, open-label trial aims to assess the practical use and effects of natriuresis-guided diuretic treatment after cardiac surgery.
CONDITIONS
Brief Title
Natriuresis-guided Depletion After Cardiac Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patient older than 18 years
- Scheduled for cardiac surgery including mitral or aortic valve repair/replacement, coronary artery bypass grafting, ascending aortic repair, or combined procedures
- Surgery with cardiopulmonary bypass planned
- Eligible to receive intravenous furosemide for fluid overload within 48 hours after surgery
- Provided written and oral informed consent
- Covered by French national health insurance
You will not qualify if you...
- Aortic arch repair with deep hypothermic circulatory arrest
- Active endocarditis
- Hemodynamic instability requiring vasopressor or inotropic support
- Failure to wean from cardiopulmonary bypass needing mechanical circulatory support
- Chronic kidney disease with estimated glomerular filtration rate below 60 mL/min
- Chronic use of loop diuretics
- Known allergy to furosemide
- Active postoperative bleeding or reoperation for bleeding
- Participation in another interventional study affecting primary outcome
- Under legal protection or deprived of liberty by judicial decision
AI-Screening
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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)
Treatment
Duration - 48 hours after randomization
Participants receive intravenous furosemide starting at 20 mg, with doses adjusted every 6 hours based on either urinary sodium levels or clinical evaluation to manage fluid overload after cardiac surgery. Urine output is measured every 4 hours, and blood tests for electrolytes and kidney function are done twice daily. Additional assessments may occur if there is hemodynamic instability.
Frequent monitoring with multiple assessments over 48 hours
Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, France, 80000
Actively Recruiting
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Research Team
C
Christophe Beyls, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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