Decompensated Heart Failure MedDRA version: 20.0 Level: LLT Classification code 10010684 Term: Congestive heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: CLORURO DE SODIO B. BRAUN 20% CONCENTRADO PARA SOLUCION PARA PERFUSION
Pharmaceutical Form: Solution for infusion in administration system
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 20%
Sponsors
Marta Cobo Marcos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age> 18 years • Previous diagnosis of HF and stable treatment the previous 4 weeks (except diuretic). • Basal treatment of at least 80 mg of furosemide daily. • Transthoracic echocardiogram performed last year. All ejection fraction (EF) groups are included. • Decompensated heart failure of congestive predominance. NTproBNP> 1000 pg / dL and the presence of at least two of the following congestion criteria will be required: Jugular pressuret> 10 cm, lower limb edema, ascites, or pleural effusion determined by chest x-ray or lung ultrasound. • Necessity at the discretion of the doctor responsible for intravenous diuretic to relieve congestion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: - Hospital admission criteria in the opinion of the responsible physician. - Systolic blood pressure 180 mmHg. - Heart rate> 150 bpm. - Basal oxygen saturation less than 90%. -Cardiogenic shock. -Acute Pulmonary Edema. - Clinically significant arrhythmia. - Acute myocardial ischemia. - Patients who are in a hemodialysis or peritoneal dialysis program. - Patients with serum sodium below 145 mEq / L or serum potassium below 3.5 mEq / L. - Hemoglobin less than 9 g / dL - Acute coronary syndrome or cardiological procedure in the previous 4 weeks. - Severe uncorrected valve disease except tricuspid regurgitation. - Moderate or severe dementia, active delirium or psychiatric problems that make the intervention difficult. - Patients in whom cardiac surgery or device implantation is planned in the following month - Pregnancy or breastfeeding - Inability to give informed consent in the absence of a legal officer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the administration of intravenous furosemide associated with hypertonic saline solution is more effective than isolated furosemide in increase diuresis in the outpatient treatment of patients with congestive heart failure;Secondary Objective: To compare both strategies in resolution of congestive data evaluated by physical examination, weight difference, biomarkers and imaging parameters (echocardioscopy) - Evaluate changes in renal function and serum ions and urine after administration of both treatments. - Assess adverse events during the first 7 and 30 days after treatment administration Need for new administration of intravenous diuretic in outpatient clinics or admission or emergency visit by heart failure Mortality or hospitalization due to heart failure Mortality or hospitalization for all causes. Worsening renal function: defined as creatinine increase = 0.3 mg / dl Ionic alterations defined as hypokalemia less than 3.5 mEq / L or hyperkalemia greater than 5.5 mEq / L;Primary end point(s): Diuresis volume during the 3 hours after administration of intravenous furosemide associated with hypertonic saline versus diuresis volume after administration of isolated intravenous furosemide, in the patient with decompensated HF in the outpatient clinics.;Timepoint(s) of evaluation of this end point: 3 hours after the treatment administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare both strategies in resolution of congestive data evaluated by physical examination, weight difference, biomarkers and imaging parameters (echocardioscopy) - Evaluate changes in renal function and serum ions and urine after administration of both treatments. - Assess adverse events during the first 7 and 30 days after treatment administration Need for new administration of intravenous diuretic in outpatient clinics or admission or emergency visit by heart failure Mortality or hospitalization due to heart failure Mortality or hospitalization for all causes. Worsening renal function: defined as creatinine increase = 0.3 mg / dl Ionic alterations defined as hypokalemia less than 3.5 mEq / L or hyperkalemia greater than 5.5 mEq / L;Timepoint(s) of evaluation of this end point: 1 week after treatment administration | — |
Countries
Spain
Contacts
Public ContactUnidad Insuficiencia Cardiaca
Hospital Universitario Puerta de Hierro Majadahonda
Outcome results
None listed