Loop Diuretics Administration and Acute Heart Failure

NCT01441245 | Completed Phase 4 Results DMC

• 1 other identifier: diuretic1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure

Keywords

acute heart failure; diuretics; BNP; Renal function; acute decompensated Heart Failure,; volume overload

Outcome Measures

Primary Outcomes (7)

• 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

  time period ranging from 72 h to 120 h.

• Evaluation of Renal Function in Terms of Creatinine Levels at Discharge

  from admission to discharge, an average of 12 days

• 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.

  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

  from admission to discharge, an average of 12 days

• Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge

  participants were followed for the duration of hospital stay, an average of 13 days

• Evaluation of Renal Function in Terms of Changes in GFR

  from admission to discharge, an average of 12 days

• Evaluation of Renal Function in Terms of GFR Values at Discharge

  from admission to discharge, an average of 12 days

Secondary Outcomes (2)

• Length of Hospitalization in the Two Groups

  in-hospital

• Dopamine Infusion During Hospitalization

  in-hospital

Study Arms (2)

Continuous furosemide infusion

EXPERIMENTAL

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

Drug: furosemide infusion

Intermittent furosemide infusion

EXPERIMENTAL

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

Drug: furosemide infusion

Interventions

furosemide infusion DRUG

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

Also known as: Continuous vs intermittent intravenous furosemide infusion

Continuous furosemide infusion; Intermittent furosemide infusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Department of Internal Medicine, Cardiology Section Center

Siena, 53100, Italy

Location

Related Publications (5)

• 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.

  PMID: 25087085 BACKGROUND

• 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.

  PMID: 21366472 RESULT

• 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.

  PMID: 31684094 DERIVED

• 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.

  PMID: 30540645 DERIVED

• 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.

  PMID: 24974232 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our study didn't explain the reasons of renal dysfunction during treatment. Concurrent evaluation of BUN could further clarify the primary defect.The multivariate analysis could be inadequate for small sample; we intend to continue enrollment.

Results Point of Contact

• Title: Alberto Palazzuoli MD, Cardiology Unit
• Organization: Department of Internal Medicine, University of Siena, Le Scotte hospital, Siena, Italy

palazzuoli2@unisi.it

+39577585363

Study Officials

• Alberto Palazzuoli, MD

  Department of Internal Medicine, Cardiology Unit, Le Scotte Hospital, Siena

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant cardiologist

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 27, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: December 28, 2017
• Last Updated: January 23, 2018
• Results First Posted: February 2, 2016

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)