Clinical trial NCT00618852: Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Official title: A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Disease
Keywords: Pediatrics
Erythrocyte Transfusion
Furosemide
Fluid Overload
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Cardiac chamber volume loading.
timeFrame: 4 hours after drug administration and 24 hours post recruitment
Secondary outcomes:
measure: Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement).
timeFrame: 4 hours after drug administration and 24 hours post recruitment
measure: Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).
timeFrame: 4 hours after drug administration and 24 hours post recruitment
measure: Changes in electrolyte balance, body weight and urine output.
timeFrame: 4 hours after drug administration and 24 hours post recruitment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Patrick McNamara, MD
role: PRINCIPAL_INVESTIGATOR
References: