About this trial
Systemic venous congestion is the primary therapeutic target of intravenous loop diuretics in patients admitted for acute heart failure (AHF). Despite their utility, a significant proportion of AHF patients are discharged with persistent clinical symptoms of congestion (residual congestion). Therefore, in recent years, there has been a growing focus on the use of tools (biomarkers, clinical ultrasound) that allow us to optimize diuretic treatment and thereby improve the prognosis of AHF patients. The objective is to analyze whether the strategy of guiding intravenous loop diuretic dosing based on intra-abdominal pressure(IAP) measurements and clinical ultrasound is superior to the conventional strategy employed in daily clinical practice. This study is a randomized, multicenter clinical trial involving consecutive patients admitted with a diagnosis of AHF in the Internal Medicine and Cardiology departments. Patients who meet the inclusion criteria, after signing informed consent, will be randomized into two groups: 1) Diuretic treatment guided by usual clinical practice and 2) Treatment guided by intra-abdominal pressure levels and clinical ultrasound (inferior vena cava and portal Doppler). This strategy will be maintained during the first 72 hours of admission, with a thorough analysis of congestion and diuretic response being conducted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women over 18 years of age.
Diagnosis of heart failure (HF) based on the latest HF guidelines published in 2022.
N-terminal pro b-type natriuretic peptide (NT-proBNP) > 1000 pg/mL or Brain Natriuretic Peptide (BNP) > 250 pg/mL.
Placement of a urinary catheter to allow for the measurement of intra-abdominal pressure.
Disqualifiers
Patient with a stay in the Internal Medicine department > 24 hours.
Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization).
Patient's refusal to participate in the clinical trial.
Inability or contraindication for urinary catheter placement.
Trial design
Parallel
Treatments tested in this trial
Furosemide 20 Milligrams
DrugDecongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound
Treatment groups
Trial outcomes
Primary outcomes
Significant reduction in congestion (ADVOR scale)
To evaluate the significant reduction in congestion (ADVOR Scale) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound). ADVOR Scale: Oedema: No oedema (0 points), Trace oedema (1 point), Clear pitting oedema (2 points), Visual deformation above ankle (3 points), Visual deformation above knee (4 points). Pleural effusion: No pleural effusion (0 points), Minor (2 points), Major (3 points) Ascites: No ascites (0 points), Minor ascites (2 points), Significant ascites (3 points) TOTAL SCORE: Oedema score + Pleural effusion + Ascitis. Minimum 0 points; Maximum 10 points
Secondary outcomes
Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines)
To evaluate the complete resolution of pulmonary congestion as assessed by ultrasound (B-lines) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound). The degree of pulmonary tissue congestion will be quantified using clinical ultrasound. Eight quadrants (four left and four right) will be examined. A quadrant will be considered positive for pulmonary tissue congestion if three or more B-lines are detected. Minimum: 0 quadrants; Maximum 8 quadrants
Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score)
To evaluate the significant reduction in intravascular congestion (inferior vena cava diameter and venous excess ultrasound protocol) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound). VEXUS score * Grade 0: No congestion; inferior vena cava vein (IVC) diameter \< 2 cms * Grade 1: Mild congestion, IVC 2\> cms + any combination of normal or mildly abnormal waveforms of doppler veins explored. * Grade 2: Moderate congestion, IVC \> 2 cms + at least one severely abnormal pattern of doppler veins explored. * Grade 3: Severe congestion, IVC \> 2cms + two or more severely abnormal waveforms of doppler veins explored. Minimum 0 points; Maximum 3 points
Total diuresis response
To evaluate the diuretic response (total urine volume/total dose of furosemide administered) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound).
Total dose of diuretic treatment
To compare the days and doses of intravenous loop diuretics and hydrochlorothiazide used during the first 72 hours of hospitalization between the standard treatment group and the intervention group.
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