Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07077772

Natriuresis-guided Depletion After Cardiac Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, 80000, France

Location status: Recruiting

Location contact

Christophe Beyls, MD, PhD

CONTACT

[email protected]

+33322087866

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Furosemide intravenous titration based on natriuresis

Drug

Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUAtwin NA-11 device.

Urine output will be measured and recorded every 4 hours to ensure accurate diuresis tracking.

If natriuresis is < 70 mmol/L, the furosemide dose will be doubled, with a maximum limit of 200 mg per bolus.

If natriuresis is ≥ 70 mmol/L, the current dose will be maintained.

Blood electrolyte panels and renal function assessments will be performed twice daily throughout the protocol.

In the event of hemodynamic instability, a complete echocardiographic assessment will be performed for all patients to detect potential surgical complications, along with a hemodynamic evaluation to guide appropriate management.

Furosemide intravenous titration based on clinical examination

Drug

Furosemide IV, 20 mg starting dose, titrated every 6 hours clinical evaluation.

Urine output will be measured and recorded every 4 hours to ensure accurate diuresis tracking.

The furosemide dosage will be adjusted based on urine output with a maximum bolus dose of 200 mg. Dose adjustments will be reassessed every 6 hours throughout the study period.

Blood electrolyte panels and renal function assessments will be performed twice daily throughout the protocol.

In the event of hemodynamic instability, a complete echocardiographic assessment will be performed for all patients to detect potential surgical complications, along with a hemodynamic evaluation to guide appropriate management.

Primary outcomes

  1. Total urine output (mL) at 48 hours after randomization.

    Time frame: 48 hours after randomization

    All patients were equipped with urinary catheters, allowing for continuous urine collection. Urine output was measured every 2 hours, and the recorded volumes were entered into a monitoring software to ensure accurate follow-up

Secondary outcomes

  1. Urine output at 24 hours

    Time frame: 24 hours after randomization

    All patients were equipped with urinary catheters, allowing for continuous urine collection. Urine output was measured every 2 hours, and the recorded volumes were entered into a monitoring software to ensure accurate follow-up.

  2. Natriuresis at 24 hours

    Time frame: 24 hours after randomization

    Total natriuresis is measured at 24 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory.

  3. Natriuresis at 48 hours

    Time frame: 48 hours after randomization

    Total natriuresis is measured at 48 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory.

  4. VExUS score at 48 hours

    Time frame: 48 hours after randomization

    The VExUS score is an echocardiographic score (ranging from 0 to 3) used to assess venous congestion at the cardiac, renal, and hepatic levels. This score will be measured after randomization and at 48 hours after randomization.

    Grade 0: IVC <2cm = No Congestion Grade 1: IVC >2cm with any combo of Normal or Mildly Abnormal Patterns = Mild Congestion Grade 2: IVC >2cm and one severely Abnormal Pattern = Moderate Congestion Grade 3: IVC >2cm and >2 Severely Abnormal Patterns = Severe Congestion

  5. Total loop diuretics

    Time frame: During the study period (48 hours)

    Total dose of loop diuretics administered during the study period (mg)

  6. Cumulative Fluid balance

    Time frame: At inclusion and 48 hours after randomization

    Fluid balance corresponds to the difference between administered fluids (intravenous infusions, blood products, enteral nutrition) and fluid losses (urine output, blood loss, digestive losses, drain output). It is calculated using the DianeRéa software (Bowmedical, version 4.8.11.22887), taking into account all fluid inputs (administered fluids, medications, nutrition) and all fluid outputs (urine, drains, perspiration) over the period from inclusion to 48 hours after randomization

  7. Number of Participants with Postoperative Complications by Day 30

    Time frame: Day 30 after randomization

    Composite outcome measuring the number of participants who experience at least one of the following postoperative complications within 30 days of surgery:

    Cardiovascular:

    • Acute left and right ventricular systolic heart failure
    • Acute circulatory failure requiring catecholamine support
    • Supraventricular (e.g., atrial fibrillation) or ventricular arrhythmias.

    Respiratory:

    • Acute respiratory distress syndrome (ARDS)
    • Prolonged orotracheal intubation (> 24 hours).
    • Reintubation.

    Renal:

    • Acute kidney injury (AKI), defined by a postoperative increase in serum creatinine of at least 50% and/or ≥ 26.5 µmol/L from baseline, and/or urine output < 0.5 mL/kg/h for ≥ 6 hours (KDIGO criteria). Serum creatinine and estimated glomerular filtration rate (eGFR) measured on the day of hospital discharge.

    Gastrointestinal:

    • Mesenteric ischemia or ischemic colitis, documented by imaging (CT scan), colonoscopy, and/or surgery.
    • Length of hospital stay (days).
    • In-hospital mortality.
  8. Number of Participants with Contraindications to Furosemide Administration

    Time frame: During the study period (48 hours after randomization)

    Number of participants presenting contraindications prior to furosemide administration, including:

    • Symptomatic hypotension
    • Hypokalemia
    • Impaired renal function
  9. Number of Corrective Measures Implemented Prior to Furosemide Administration

    Time frame: Within 48 hours after randomization

    Number of participants for whom corrective actions (e.g., potassium supplementation, fluid resuscitation) were implemented to allow safe administration of furosemide.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Beyls, MD, PhD

CONTACT

[email protected]

+33322087866

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial

Acronym: EASY-CS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.