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Loop Diuretics Administration and Acute Heart Failure (diurHF)

This study is currently recruiting participants.
Verified September 2011 by University of Siena
Sponsor:
Information provided by (Responsible Party):
Alberto Palazzuoli MD PhD, University of Siena
ClinicalTrials.gov Identifier:
NCT01441245
First received: September 22, 2011
Last updated: September 23, 2011
Last verified: September 2011
History of Changes

September 22, 2011
September 23, 2011
April 2010
February 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01441245 on ClinicalTrials.gov Archive Site
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
Same as current
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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.
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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

consecutive patient sampling with diagonsis of acute heart failure, volume overload and needing for furosemide infusion
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
November 2012
February 2011   (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
40 Years to 90 Years
No
Contact: Alberto Palazzuoli, MD +39577585363 palazzuoli2@unisi.it
Italy
 
NCT01441245
diuretic1
Yes
Alberto Palazzuoli MD PhD, University of Siena
University of Siena
Not Provided
Not Provided
University of Siena
September 2011

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