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Completed

NCT Number: NCT01441245

Loop Diuretics Administration and Acute Heart Failure

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal Medicine, Cardiology Section Center

Siena, 53100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

furosemide infusion

Drug

Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours

Other names: Continuous vs intermittent intravenous furosemide infusion

Primary outcomes

  1. Evaluation of Mean Urine Output Volume During the Infusion Period

    Time frame: 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

  2. Evaluation of Renal Function in Terms of Creatinine Levels at Discharge

    Time frame: from admission to discharge, an average of 12 days

  3. Evaluation of Renal Function in Terms of Changes in Creatinine Levels

    Time frame: 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.

  4. Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment

    Time frame: from admission to discharge, an average of 12 days

  5. Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge

    Time frame: participants were followed for the duration of hospital stay, an average of 13 days

  6. Evaluation of Renal Function in Terms of Changes in GFR

    Time frame: from admission to discharge, an average of 12 days

  7. Evaluation of Renal Function in Terms of GFR Values at Discharge

    Time frame: from admission to discharge, an average of 12 days

Secondary outcomes

  1. Length of Hospitalization in the Two Groups

    Time frame: in-hospital

    percentage of participants with hospital stay > 10 days

  2. Dopamine Infusion During Hospitalization

    Time frame: in-hospital

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

Continuous Versus Intermittent Loop Diuretics Infusion Dosing in Acute Heart Failure: Effects on Renal Function, Outcome and BNP Levels

Acronym: diurHF

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Sep 27, 2011
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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