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Withdrawn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
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
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
NCT ID
NCT01705470
First Posted
October 9, 2012
Last Updated
June 27, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
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Withdrawn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
We'll reach out to this number within 24 hrs