Efficacy and Safety of Intravenous Furosemide administered with Hypertonic Saline Solution at the Heart Failure Day Hospital. SSH-IC study - SSH-IC trial

Marta Cobo Marcos0 个研究点目标入组 168 人开始时间: 2020年3月6日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•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

•- Hospital admission criteria in the opinion of the responsible physician.
•- Systolic blood pressure <90 mmHg or> 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 <125 mEq / L or> 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.

发起方

Marta Cobo Marcos