Lung Disease
Conditions
Keywords
Pediatrics, Erythrocyte Transfusion, Furosemide, Fluid Overload
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.
Interventions
DRUGFurosemide
The dose of furosemide will be 1 mg/kg by intravenous bolus injection
DRUGSaline
1 mg/kg by intravenous bolus injection
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 44 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac chamber volume loading. | 4 hours after drug administration and 24 hours post recruitment |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement). | 4 hours after drug administration and 24 hours post recruitment |
| Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam). | 4 hours after drug administration and 24 hours post recruitment |
| Changes in electrolyte balance, body weight and urine output. | 4 hours after drug administration and 24 hours post recruitment |
Countries
Canada
Contacts
Primary ContactPatrick McNamara, MD
Outcome results
None listed