An interventional study of Furosemide intravenous titration based on natriuresis and Furosemide intravenous titration based on clinical examination in Cardiac Surgery, Diuresis and Congestion, Venous, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Treatment
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.
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 102 is above the median of 68 across 51 interventional studies indexed under Hyperemia.
Browse Hyperemia studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUATWIN device.
Drug: Furosemide intravenous titration based on natriuresis
Furosemide IV, 20 mg starting dose, titrated every 6 hours based on clinical evaluation
Drug: Furosemide intravenous titration based on clinical examination
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 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.
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
Time frame: 48 hours after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 48 hours after randomization
Total loop diuretics
Total dose of loop diuretics administered during the study period (mg)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Within 48 hours after randomization
Plan to share: 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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