CHU Amiens Picardie
Amiens, 80000, France
Location status: Recruiting
NCT Number: NCT07077772
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amiens, 80000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
Time frame: 24 hours after randomization
Total natriuresis is measured at 24 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory.
Time frame: 48 hours after randomization
Total natriuresis is measured at 48 hours using the indirect potentiometry technique at the CHU Amiens-Picardie laboratory.
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
Time frame: During the study period (48 hours)
Total dose of loop diuretics administered during the study period (mg)
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
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:
Respiratory:
Renal:
Gastrointestinal:
Time frame: During the study period (48 hours after randomization)
Number of participants presenting contraindications prior to furosemide administration, including:
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial
Acronym: EASY-CS
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.
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