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Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

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ClinicalTrials.gov Identifier: NCT00618852
Recruitment Status : Unknown
Verified February 2008 by The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : February 20, 2008
Last Update Posted : February 20, 2008
Sponsor:
Information provided by:
The Hospital for Sick Children

Brief Summary:
The purpose of this study is to investigate the effects of intravenous furosemide on cardio-respiratory performance in neonates receiving a packed red blood cell (PRBC) transfusion who are considered at high risk of volume overload.

Condition or disease Intervention/treatment Phase
Lung Disease Drug: Furosemide Drug: Saline Phase 3

Detailed Description:
Red cell transfusion is a very common practice in neonates, particularly in preterm infants. It has been estimated that approximately 300,000 neonates undergo transfusions annually. The decision to administer a blood transfusion to a sick anemic neonate is made after consideration of multiple clinical factors, including: poor weight gain, oxygenation failure, and recurrent apnea and bradycardia. These decisions are also influenced by physician preferences. For many years, furosemide has been used routinely by physicians during and after blood transfusions in neonates and other age groups. The rationale behind this common practice is to reduce the vascular overload that may be imposed by the additional blood volume delivered during transfusion. This belief, however, lacks the support of scientific clinical evaluation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Study Start Date : January 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: 1
Furosemide
Drug: Furosemide
The dose of furosemide will be 1 mg/kg by intravenous bolus injection

Placebo Comparator: 2 Drug: Saline
1 mg/kg by intravenous bolus injection




Primary Outcome Measures :
  1. Cardiac chamber volume loading. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ]

Secondary Outcome Measures :
  1. Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement). [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ]
  2. Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam). [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ]
  3. Changes in electrolyte balance, body weight and urine output. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ]


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Ages Eligible for Study:   up to 44 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Less than 44 weeks corrected gestational age
  • Receiving a red cell transfusion
  • Satisfy one of the following criteria:

    • Echocardiographic evidence of a hemodynamically significant ductus arteriosus (HSDA) defined by a transductal diameter >1.5 mm and unrestrictive systemic-pulmonary trans-ductal flow
    • Clinical evidence of significant lung disease defined by a need for respiratory support (assisted ventilation or nasal CPAP) and oxygen supplementation after 28 days of age

Exclusion Criteria:

  • Infants with multiple congenital anomalies or renal insufficiency
  • Infants with hypotension, hypertension, or on any cardiac medication
  • Infants with sepsis causing compromised clinical condition such as disseminated intravascular coagulopathy
  • Infants with contra-indications to diuretic therapy, such as significant electrolyte imbalance, or endocrine disease

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): NCT00618852


Contacts
Contact: Patrick McNamara, MD 416-813-5773 patrick.mcnamara@sickkids.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Edmond Kelley, MD    416-586-5310    ekelly@mtsinai.on.ca   
Principal Investigator: Edmond Kelley, MD         
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Patrick McNamara, MD    416 813 5773    patrick.mcnamara@sickkids.ca   
Principal Investigator: Patrick McNamara, MD         
Sub-Investigator: Walid El-Naggar, MD         
Sub-Investigator: Anna Taddio, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Patrick McNamara, MD The Hospital for Sick Children, Toronto Canada

Responsible Party: Patrick McNamara/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00618852     History of Changes
Other Study ID Numbers: 1000009083
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: February 20, 2008
Last Verified: February 2008

Keywords provided by The Hospital for Sick Children:
Pediatrics
Erythrocyte Transfusion
Furosemide
Fluid Overload

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action