Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide

Study Overview

• Status: Withdrawn
• Conditions: Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction
• Intervention / Treatment: Drug: furosemide; Drug: placebo normal saline

Detailed Description

More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.

Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is over 18 years old.
• Documented ejection function equal to or over 40% in prior tests
• The treating physician decided to treat the patient with packed cell

Exclusion Criteria:

• Known hypersensitivity to furosemide.
• Calculated creatinine clearance over 20% (by MDRD)
• Past adverse reaction to blood product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm1; will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).	Drug: furosemide
Experimental: arm2; will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).	Drug: placebo normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment	Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment	Within 4 hours from receiving the blood transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome following blood transfusion, with or without Furosemide treatment	clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation	Within 4 hours from receiving the blood transfusion

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Edo Birati, MD, Tel Aviv MC

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Anemia; blood transfusion; Furosemide; LV dysfunction
• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: SHERLOCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO