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Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

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ClinicalTrials.gov Identifier: NCT01705470
Recruitment Status : Withdrawn (PI left the medical center, no replacement assigned)
First Posted : October 12, 2012
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment
Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction 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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2012
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment [ Time Frame: Within 4 hours from receiving the blood transfusion ]
    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 :
  1. clinical outcome following blood transfusion, with or without Furosemide treatment [ Time Frame: Within 4 hours from receiving the blood transfusion ]
    clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705470


Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Edo Birati, MD Tel Aviv MC

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01705470     History of Changes
Other Study ID Numbers: SHERLOCK
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tel-Aviv Sourasky Medical Center:
Furosemide
Anemia
LV dysfunction
blood transfusion

Additional relevant MeSH terms:
Stress, Psychological
Ventricular Dysfunction, Left
Behavioral Symptoms
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action