acute decompensated congestive heart failure MedDRA version: 9.1 Level: LLT Classification code 10064652
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Dopamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical Form:
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent On admission - Age 18-80 years - NYHA class III IV - Signs of pulmonary (pulmonary rales, and interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (pitting ankle oedema and enlarged liver or ascites and neck vein distension ≥ 7 cm) and weight gain ≥ 2 kg during the previous week - Glomerular filtration rate ≥ 30 ml/min - BNP increased >400 pg/ml (diagnostic cut-off for ADCHF), as confirmatory diagnostic test28 24 hours after admission (randomization) - Persistents signs of pulmonary (pulmonary rales, interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (ankle oedema, enlarged liver or ascites, neck vein distension ≥ 7 cm) - Serum creatinine or urine output criteria indicative of modified RIFLE (AKI: risk) class at least 1 (increase x 1.5 in serum creatinine or decrease > 25% in GFR or urine output =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Chronic kidney disease stage 4-5 (GFR 45% - Unattainable venous access - Contraindications to anticoagulation by heparin - Systemic infection - Heart transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of the present project are to evaluate whether in patients with acute decompensated congestive heart failure (ADCHF) and the cardiorenal syndrome, i.e. a state in which therapy directed to improve CHF symptoms is limited by further worsening renal function, fluid removal by ultrafiltration (UF) is superior to different pharmacological approaches in acutely relieving congestion and preventing further deterioration in renal function (clinical and laboratory improvement at 96 h)and whether it results in longer admission-free survival 90 days after enrolment;Secondary Objective: Furthermore the study aims to assess the predictive role of biomarker levels in relation to clinical improvement and renal function changes. Information gathered from this study will include - safety of ultrafiltration in the intensive cardiology care unit - correlation of NGAL profile and time course of renal dysfunction during hospital stay - correlation of BNP profile, changes in volume overload, clinical improvement;Primary end point(s): Improvement in a composite clinical-lab score expressed as a score ≥2 (see below) | — |
Countries
Italy
Outcome results
None listed