Loop Diuretics Administration and Acute Heart Failure

Phase 4

Completed

Conditions: Acute Heart Failure

Interventions: Drug: furosemide infusion

Registration Number: NCT01441245

Lead Sponsor: University of Siena

Brief Summary: Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion and systemic fluid overload. In theory, continuous infusion should allow for a more consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the neurohormonal activation. This should lead to renal function improvement and BNP decrease.

Detailed Description: Patients were eligible if they were admitted with a primary diagnosis of ADHF, randomized within 12 h after hospital presentation, and with evidence of volume overload (pulmonary congestion) on a chest X-ray study and had BNP levels \>100 pg/ml. Patients also displayed mild to moderate renal dysfunction with creatinine values up to 1.4 mg/dl. Some patients were supported with non invasive ventilation before randomization. Once the initial 12 h dose was determined, patients were randomized using a 1:1 ratio using a computer-generated scheme to receive the furosemide dose either divided into a twice-daily bolus injection or in a continuous infusion (mixed as a 1:1 ratio in 5 % dextrose in water) for a time period ranging from 72 to 120 h. The randomization was casual, and the physicians did not previously know the assigned arm. The dose escalation and subsequent titration of furosemide was guided by clinical response in terms of urine output volume and body weight reduction .Before randomization, renal function parameters and BNP levels were measured in all patients. Subsequent titration of the furosemide dosage was at the discretion of the attending physician, but was guided by a dose-escalation algorithm based on the treatment response (weight loss and urine output volume), symptom improvement, changes in renal function, electrolyte balance, and chest radiography. The specific doses of furosemide and the use of additional agents to manage ADHF (dopamine, IV vasodilators, hypertonic saline infusion) were decided based upon blood pressure measurements, renal function evaluation and diuresis response. Supplementary treatment was left to the discretion of the treating physician. The duration of infusion was continued for up to 72 h, at 48 h the physicians had the possibility to adjust diuretic dose administration on the basis of the clinical response. After 72 h the treatment could be stopped or continued for an additional 36-48 h depending on the patient's condition and diuresis response. Acute kidney injury (AKI) was defined following the RIFLE criteria.

Abbreviations:

(AKI) Acute kidney injury (ADHF) Acute decompensated heart failure (BNP) B-type natriuretic peptide (CHD) Coronary heart disease (cIV) Continuous infusion (iIV) Intermittent infusione (eGFR)Estimated glomerular filtration rate (Hb) Hemoglobin (HF) Heart failure (Hct) Hematocrit (LVEF) Left ventricular ejection fraction (RBC) Red blood cells

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 57

Inclusion Criteria

Patients took part in the random sample selection if they met the diagnostic criteria for acute decompensated HF.
Patients with primary diagnosis of ADHF, volume overload with cardia dilation and LVEF <50%, and had BNP levels >100 pg/ml.

Exclusion Criteria

Patients were excluded if they had received more than 2 IV doses of furosemide or any continuous infusion of furosemide 1 month before randomization
If they had end-stage renal disease or the need for renal replacement therapy, isolated diastolic dysfunction.
Recent myocardial infarction

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous furosemide infusion	furosemide infusion	The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients;
Intermittent furosemide infusion	furosemide infusion	The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients

Primary Outcome Measures

Name	Time	Method
Evaluation of Mean Urine Output Volume During the Infusion Period	time period ranging from 72 h to 120 h.	this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge
Evaluation of Renal Function in Terms of Creatinine Levels at Discharge	from admission to discharge, an average of 12 days
Evaluation of Renal Function in Terms of Changes in Creatinine Levels	participants were followed for the duration of hospital stay, an average of 13 days	evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.
Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment	from admission to discharge, an average of 12 days
Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge	participants were followed for the duration of hospital stay, an average of 13 days
Evaluation of Renal Function in Terms of Changes in GFR	from admission to discharge, an average of 12 days
Evaluation of Renal Function in Terms of GFR Values at Discharge	from admission to discharge, an average of 12 days

Secondary Outcome Measures

Name	Time	Method
Dopamine Infusion During Hospitalization	in-hospital
Length of Hospitalization in the Two Groups	in-hospital	percentage of participants with hospital stay \> 10 days