Cardiac SurgeryEASY-CSNCT07077772
Natriuresis-guided Depletion After Cardiac Surgery
A study testing Furosemide intravenous titration based on natriuresis and Furosemide intravenous titration based on clinical examination in people with Cardiac Surgery and Diuresis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Diuresis, Congestion, Venous
- What is being tested?
- Furosemide intravenous titration based on natriuresis and Furosemide intravenous titration based on clinical examination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, 80000
Christophe Beyls, MD, PhD, +33322087866, beyls.christophe@chu-amiens.fr
About this study
Official title: Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
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.
- Conditions
- Cardiac Surgery, Diuresis, Congestion, Venous, Sodium Depletion, Fluid Over-load
- Being tested
- Furosemide intravenous titration based on natriuresis, Furosemide intravenous titration based on clinical examination
- Keywords
- natriuresis, fluid overload, cardiac surgery, furosemide, venous congestion, loop diuretics
- Medical subject headings
- Hyperemia, Hyponatremia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide intravenous titration based on natriuresisDrug
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 examinationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Natriuresis-Guided Arm | Experimental | Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device. Receives: Drug: Furosemide intravenous titration based on natriuresis |
| Control | Active comparator | Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation Receives: Drug: Furosemide intravenous titration based on clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total urine output (mL) at 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
Measured: 48 hours after randomization
Secondary outcomes (9)
Urine output at 24 hours
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.
Measured: 24 hours after randomization
Natriuresis at 24 hours
Total natriuresis is measured at 24 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory.
Measured: 24 hours after randomization
Natriuresis at 48 hours
Total natriuresis is measured at 48 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory.
Measured: 48 hours after randomization
VExUS score at 48 hours
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
Measured: 48 hours after randomization
Total loop diuretics
Total dose of loop diuretics administered during the study period (mg)
Measured: During the study period (48 hours)
Cumulative Fluid balance
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
Measured: At inclusion and 48 hours after randomization
Number of Participants with Postoperative Complications by Day 30
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.
Measured: Day 30 after randomization
Number of Participants with Contraindications to Furosemide Administration
Number of participants presenting contraindications prior to furosemide administration, including:
- Symptomatic hypotension
- Hypokalemia
- Impaired renal function
Measured: During the study period (48 hours after randomization)
Number of Corrective Measures Implemented Prior to Furosemide Administration
Number of participants for whom corrective actions (e.g., potassium supplementation, fluid resuscitation) were implemented to allow safe administration of furosemide.
Measured: Within 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Jun 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium (experimental) or clinical evaluation (control) The investigators predefined safety criteria to be assessed prior to each furosemide injection in order to monitor potential complications related to its administration, including: * Symptomatic hypotension, defined as a mean arterial pressure \< 65 mmHg requiring fluid resuscitation or vasopressor support; * Hypokalemia, defined as a serum potassium concentration \< 3 mmol/L; * Impaired renal function, defined as a doubling of serum creatinine or a ≥50% decrease in estimated glomerular filtration rate (eGFR) within the first 48 hours. The study protocol will be implemented over a 48-hour timeframe starting from patient inclusion.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyls, Centre Hospitalier Universitaire, Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077772
- Sponsor's protocol ID
- PI2025_843_0080
- Acronym
- EASY-CS
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared. However, reasonable requests from qualified researchers will be considered after publication of the main results, subject to data use agreements and ethical approval
Publications
Beyls C, Mollet N, Gibert L, Huette P, Khamari M, Meynier J, Abou-Arab O, Mahjoub Y. Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial-the EASY-CS study. BMJ Open. 2025 Oct 6;15(10):e108600. doi: 10.1136/bmjopen-2025-108600.
PubMed 41057198
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07077772
- Acronym / sponsor ID
- EASY-CS / PI2025_843_0080
- Conditions
- Cardiac Surgery, Diuresis, Congestion, Venous, Sodium Depletion, Fluid Over-load
- Keywords
- natriuresis, fluid overload, cardiac surgery, furosemide, venous congestion, loop diuretics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium (experimental) or clinical evaluation (control) The investigators predefined safety criteria to be assessed prior to each furosemide injection in order to monitor potential complications related to its administration, including: * Symptomatic hypotension, defined as a mean arterial pressure < 65 mmHg requiring fluid resuscitation or vasopressor support; * Hypokalemia, defined as a serum potassium concentration < 3 mmol/L; * Impaired renal function, defined as a doubling of serum creatinine or a ≥50% decrease in estimated glomerular filtration rate (eGFR) within the first 48 hours. The study protocol will be implemented over a 48-hour timeframe starting from patient inclusion.
| Arm | Type | Receives |
|---|---|---|
| Natriuresis-Guided Arm | Experimental | Drug: Furosemide intravenous titration based on natriuresisFurosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device. |
| Control | Active comparator | Drug: Furosemide intravenous titration based on clinical examinationFurosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide intravenous titration based on natriuresisFurosemide 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. | Drug | Natriuresis-Guided Arm |
| Furosemide intravenous titration based on clinical examinationFurosemide 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. | Drug | Control |
Primary outcome
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
9 secondary outcomes
Urine output at 24 hours
Time frame: 24 hours after randomization
Natriuresis at 24 hours
Time frame: 24 hours after randomization
Natriuresis at 48 hours
Time frame: 48 hours after randomization
VExUS score at 48 hours
Time frame: 48 hours after randomization
Total loop diuretics
Time frame: During the study period (48 hours)
Cumulative Fluid balance
Time frame: At inclusion and 48 hours after randomization
Number of Participants with Postoperative Complications by Day 30
Time frame: Day 30 after randomization
Number of Participants with Contraindications to Furosemide Administration
Time frame: During the study period (48 hours after randomization)
Number of Corrective Measures Implemented Prior to Furosemide Administration
Time frame: Within 48 hours after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 41057198Beyls C, Mollet N, Gibert L, Huette P, Khamari M, Meynier J, Abou-Arab O, Mahjoub Y. Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial-the EASY-CS study. BMJ Open. 2025 Oct 6;15(10):e108600. doi: 10.1136/bmjopen-2025-108600.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared. However, reasonable requests from qualified researchers will be considered after publication of the main results, subject to data use agreements and ethical approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide intravenous titration based on natriuresis and Furosemide intravenous titration based on clinical examination in people with Cardiac Surgery and Diuresis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Beyls, MD, PhD (+33322087866, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total urine output (mL) at 48 hours after randomization. (time frame: 48 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.