Natriuresis-guided Depletion After Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Furosemide intravenous titration based on natriuresis
DrugFurosemide 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
DrugFurosemide 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Natriuresis-Guided ArmExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 randomizationSecondary outcomes
1
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 randomization2
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 randomization3
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 randomization4
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 randomizationSponsors and contacts
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Source ClinicalTrials.gov