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Loop Diuretics Administration and Acute Heart Failure (diurHF)

Primary Purpose

Acute Heart Failure

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
furosemide infusion
Sponsored by
University of Siena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring acute heart failure, diuretics, BNP, Renal function, acute decompensated Heart Failure,, volume overload

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, Cardiology Section Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Continuous furosemide infusion

Intermittent furosemide infusion

Arm Description

The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients;

The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients

Outcomes

Primary Outcome Measures

Evaluation of Mean Urine Output Volume During the Infusion Period
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
Evaluation of Renal Function in Terms of Changes in Creatinine Levels
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
Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge
Evaluation of Renal Function in Terms of Changes in GFR
Evaluation of Renal Function in Terms of GFR Values at Discharge

Secondary Outcome Measures

Length of Hospitalization in the Two Groups
percentage of participants with hospital stay > 10 days
Dopamine Infusion During Hospitalization

Full Information

First Posted
September 22, 2011
Last Updated
December 28, 2017
Sponsor
University of Siena
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1. Study Identification

Unique Protocol Identification Number
NCT01441245
Brief Title
Loop Diuretics Administration and Acute Heart Failure
Acronym
diurHF
Official Title
Continuous Versus Intermittent Loop Diuretics Infusion Dosing in Acute Heart Failure: Effects on Renal Function, Outcome and BNP Levels
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Siena

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
acute heart failure, diuretics, BNP, Renal function, acute decompensated Heart Failure,, volume overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous furosemide infusion
Arm Type
Experimental
Arm Description
The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients;
Arm Title
Intermittent furosemide infusion
Arm Type
Experimental
Arm Description
The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients
Intervention Type
Drug
Intervention Name(s)
furosemide infusion
Other Intervention Name(s)
Continuous vs intermittent intravenous furosemide infusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of Mean Urine Output Volume During the Infusion Period
Description
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
Time Frame
time period ranging from 72 h to 120 h.
Title
Evaluation of Renal Function in Terms of Creatinine Levels at Discharge
Time Frame
from admission to discharge, an average of 12 days
Title
Evaluation of Renal Function in Terms of Changes in Creatinine Levels
Description
evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.
Time Frame
participants were followed for the duration of hospital stay, an average of 13 days
Title
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
Title
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
Title
Evaluation of Renal Function in Terms of Changes in GFR
Time Frame
from admission to discharge, an average of 12 days
Title
Evaluation of Renal Function in Terms of GFR Values at Discharge
Time Frame
from admission to discharge, an average of 12 days
Secondary Outcome Measure Information:
Title
Length of Hospitalization in the Two Groups
Description
percentage of participants with hospital stay > 10 days
Time Frame
in-hospital
Title
Dopamine Infusion During Hospitalization
Time Frame
in-hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Palazzuoli, MD
Organizational Affiliation
Department of Internal Medicine, Cardiology Unit, Le Scotte Hospital, Siena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Cardiology Section Center
City
Siena,
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25087085
Citation
Palazzuoli A, Pellegrini M, Franci B, Beltrami M, Ruocco G, Gonnelli S, Angelini GD, Nuti R. Short and long-term effects of continuous versus intermittent loop diuretics treatment in acute heart failure with renal dysfunction. Intern Emerg Med. 2015 Feb;10(1):41-9. doi: 10.1007/s11739-014-1112-5. Epub 2014 Aug 3.
Results Reference
background
PubMed Identifier
21366472
Citation
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; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
Results Reference
result
PubMed Identifier
31684094
Citation
Ruocco G, Feola M, Nuti R, Luschi L, Evangelista I, Palazzuoli A. Loop Diuretic Administration in Patients with Acute Heart Failure and Reduced Systolic Function: Effects of Different Intravenous Diuretic Doses and Diuretic Response Measurements. J Clin Med. 2019 Nov 2;8(11):1854. doi: 10.3390/jcm8111854.
Results Reference
derived
PubMed Identifier
30540645
Citation
Ruocco G, Evangelista I, Franci B, Lucani B, Martini S, Nuti R, Palazzuoli A. Combination of ST2 and B-type natriuretic peptide in diabetic patients with acute heart failure: relation with ventricular stiffness and outcome. J Cardiovasc Med (Hagerstown). 2019 Feb;20(2):81-90. doi: 10.2459/JCM.0000000000000741.
Results Reference
derived
PubMed Identifier
24974232
Citation
Palazzuoli A, Pellegrini M, Ruocco G, Martini G, Franci B, Campagna MS, Gilleman M, Nuti R, McCullough PA, Ronco C. Continuous versus bolus intermittent loop diuretic infusion in acutely decompensated heart failure: a prospective randomized trial. Crit Care. 2014 Jun 28;18(3):R134. doi: 10.1186/cc13952.
Results Reference
derived

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Loop Diuretics Administration and Acute Heart Failure

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