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Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

Primary Purpose

Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
furosemide
placebo normal saline
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction focused on measuring Furosemide, Anemia, LV dysfunction, blood transfusion

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    arm1

    arm2

    Arm Description

    will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).

    will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    October 9, 2012
    Last Updated
    June 27, 2016
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01705470
    Brief Title
    Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left the medical center, no replacement assigned
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction
    Keywords
    Furosemide, Anemia, LV dysfunction, blood transfusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    arm1
    Arm Type
    Experimental
    Arm Description
    will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).
    Arm Title
    arm2
    Arm Type
    Experimental
    Arm Description
    will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).
    Intervention Type
    Drug
    Intervention Name(s)
    furosemide
    Intervention Type
    Drug
    Intervention Name(s)
    placebo normal saline
    Primary Outcome Measure Information:
    Title
    Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment
    Description
    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
    Time Frame
    Within 4 hours from receiving the blood transfusion
    Secondary Outcome Measure Information:
    Title
    clinical outcome following blood transfusion, with or without Furosemide treatment
    Description
    clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation
    Time Frame
    Within 4 hours from receiving the blood transfusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edo Birati, MD
    Organizational Affiliation
    Tel Aviv MC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

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