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Loop Diuretics Administration and Acute Heart Failure (diurHF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alberto Palazzuoli MD PhD, University of Siena
ClinicalTrials.gov Identifier:
NCT01441245
First received: September 22, 2011
Last updated: January 2, 2016
Last verified: January 2016

September 22, 2011
January 2, 2016
April 2010
December 2012   (final data collection date for primary outcome measure)
  • Evaluation of Mean Urine Output Volume During the Infusion Period [ Time Frame: time period ranging from 72 h to 120 h. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from admission to discharge, an average of 12 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from admission to discharge, an average of 12 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluation of Renal Function in Terms of Changes in GFR [ Time Frame: from admission to discharge, an average of 12 days ] [ Designated as safety issue: Yes ]
  • Evaluation of Renal Function in Terms of GFR Values at Discharge [ Time Frame: from admission to discharge, an average of 12 days ] [ Designated as safety issue: Yes ]
evaluation of renal function and BNP levels during loop diuretic infusion [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
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, and BNP levels from admission to discharge
Complete list of historical versions of study NCT01441245 on ClinicalTrials.gov Archive Site
  • Length of Hospitalization in the Two Groups [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
    percentage of participants with hospital stay > 10 days
  • Dopamine Infusion During Hospitalization [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
length of hospitalization and evaluation of cardiac events in the two groups [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Secondary endpoints included: length of hospitalization, evaluation of cardiac events in terms of death and hospitalization during a 6-months follow up period, change in weight loss, evaluation of the electrolyte balance during the hospital stay
Not Provided
Not Provided
 
Loop Diuretics Administration and Acute Heart Failure
Continuous Versus Intermittent Loop Diuretics Infusion Dosing in Acute Heart Failure: Effects on Renal Function, Outcome and BNP Levels
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Heart Failure
Drug: furosemide infusion
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 Name: Continuous vs intermittent intravenous furosemide infusion
  • Experimental: Continuous furosemide infusion
    The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients;
    Intervention: Drug: furosemide infusion
  • Experimental: Intermittent furosemide infusion
    The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients
    Intervention: Drug: furosemide infusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
September 2018
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients took part in the random sample selection if they met the diagnostic criteria for acute decompensated HF.
  • They also displayed impaired ejection fraction (LVEF <45%) with cardiac dilatation and pulmonary hypertension

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01441245
diuretic1
Yes
Not Provided
Not Provided
Alberto Palazzuoli MD PhD, University of Siena
University of Siena
Not Provided
Principal Investigator: Alberto Palazzuoli, MD Department of Internal Medicine, Cardiology Unit, Le Scotte Hospital, Siena
University of Siena
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP