Loop Diuretics Administration and Acute Heart Failure (diurHF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Siena.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Acute Heart Failure
Drug: furosemide infusion
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Continuous Versus Intermittent Loop Diuretics Infusion Dosing in Acute Heart Failure: Effects on Renal Function, Outcome and BNP Levels

Resource links provided by NLM:


Further study details as provided by University of Siena:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 58
Study Start Date: April 2010
Estimated Study Completion Date: November 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

consecutive patient sampling with diagonsis of acute heart failure, volume overload and needing for furosemide infusion

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441245

Contacts
Contact: Alberto Palazzuoli, MD +39577585363 palazzuoli2@unisi.it

Locations
Italy
Department of Internal Medicine, Cardiology Section Center Recruiting
Siena,, Italy, 53100
Contact: Alberto Palazzuoli, MD    +39577585363    palazzuoli2@unisi.it   
Principal Investigator: Alberto Palazzuoli, MD         
Sponsors and Collaborators
University of Siena
  More Information

Publications:
-Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM. Diuretic strategies in acute decompensated heart failure. N Engl J Med 2011; 364: 797-805

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alberto Palazzuoli MD PhD, Consultant cardiologist, University of Siena
ClinicalTrials.gov Identifier: NCT01441245     History of Changes
Other Study ID Numbers: diuretic1
Study First Received: September 22, 2011
Last Updated: September 23, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Siena:
acute heart failure
diuretics
BNP
Renal function
acute decompensated Heart Failure,
volume overload

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Furosemide
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014