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Natriuresis-guided Depletion After Cardiac Surgery (EASY-CS)

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Cardiac Surgery
Fluid Over-load
Congestion, Venous
Sodium Depletion
Diuresis

Treatments

Drug: Furosemide intravenous titration based on natriuresis
Drug: Furosemide intravenous titration based on clinical examination

Study type

Interventional

Funder types

Other

Identifiers

NCT07077772
PI2025_843_0080

Details and patient eligibility

About

Fluid overload (FO) is a common complication after cardiac surgery, associated with increased morbidity and mortality. Loop diuretics, especially furosemide, are routinely used to manage FO, but their use is often empirical. Recent data suggest that natriuresis-guided furosemide titration using point-of-care urinary sodium sensors (LAQUAtwin NA-11, Horiba) may improve the efficiency and safety of fluid removal, but no randomized trial has yet evaluated this approach in postoperative cardiac surgery patients

Our goal is to assess the clinical impact, safety, and feasibility of a natriuresis-guided furosemide protocol after cardiac surgery requiring cardiopulmonary bypass.

Enrollment

102 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patient (age > 18 years)
  • Scheduled for cardiac surgery, including mitral valve repair or replacement, aortic valve replacement, coronary artery bypass grafting (CABG), ascending aortic repair, or combined procedures
  • Undergoing surgery with cardiopulmonary bypass (CPB)
  • Eligible to receive intravenous furosemide for fluid overload within 48 hours following surgery, as prescribed by the referring physician
  • Written and oral informed consent obtained
  • Covered by the French national health insurance (Sécurité Sociale)

Exclusion criteria

  • Aortic arch repair requiring deep hypothermic circulatory arrest
  • Active endocarditis
  • Hemodynamic instability requiring vasopressor or inotropic support (norepinephrine, dobutamine, epinephrine, or vasopressin)
  • Failure to wean from CPB requiring mechanical circulatory support
  • Chronic kidney disease with an estimated glomerular filtration rate (eGFR) < 60 mL/min
  • Chronic use of loop diuretics
  • Known allergy to furosemide
  • Active postoperative bleeding and/or reoperation for bleeding
  • Participation in another interventional study that may affect the primary outcome measure
  • Patient deprived of liberty by administrative or judicial decision, or placed under legal protection (guardianship or curatorship)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Natriuresis-Guided Arm
Experimental group
Description:
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device.
Treatment:
Drug: Furosemide intravenous titration based on natriuresis
Control
Active Comparator group
Description:
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation
Treatment:
Drug: Furosemide intravenous titration based on clinical examination

Trial contacts and locations

1

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Central trial contact

Christophe Beyls, MD, PhD

Data sourced from clinicaltrials.gov

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