Loop Diuretics Administration and Acute Heart Failure (diurHF)

December 28, 2017 updated by: Alberto Palazzuoli MD PhD, University of Siena

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena,, Italy, 53100
        • Department of Internal Medicine, Cardiology Section Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continuous furosemide infusion
The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients;
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 Names:
  • Continuous vs intermittent intravenous furosemide infusion
EXPERIMENTAL: Intermittent furosemide infusion
The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients
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 Names:
  • Continuous vs intermittent intravenous furosemide infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
time period ranging from 72 h to 120 h.
Evaluation of Renal Function in Terms of Creatinine Levels at Discharge
Time Frame: from admission to discharge, an average of 12 days
from admission to discharge, an average of 12 days
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.
participants were followed for the duration of hospital stay, an average of 13 days
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
from admission to discharge, an average of 12 days
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
participants were followed for the duration of hospital stay, an average of 13 days
Evaluation of Renal Function in Terms of Changes in GFR
Time Frame: from admission to discharge, an average of 12 days
from admission to discharge, an average of 12 days
Evaluation of Renal Function in Terms of GFR Values at Discharge
Time Frame: from admission to discharge, an average of 12 days
from admission to discharge, an average of 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospitalization in the Two Groups
Time Frame: in-hospital
percentage of participants with hospital stay > 10 days
in-hospital
Dopamine Infusion During Hospitalization
Time Frame: in-hospital
in-hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Investigators

  • Principal Investigator: Alberto Palazzuoli, MD, Department of Internal Medicine, Cardiology Unit, Le Scotte Hospital, Siena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

December 28, 2017

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (ESTIMATE)

September 27, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diuretic1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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