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

Lung Disease Clinical Trial

Official title:

A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00618852
• Other study ID #: 1000009083
• Status: Recruiting
• Phase: Phase 3
• First received: February 7, 2008
• Last updated: February 19, 2008
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: February 2008
• Source: The Hospital for Sick Children
• Contact: Patrick McNamara, MD
• Phone: 416-813-5773
• Email: patrick.mcnamara[@]sickkids.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 44 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

Drug:
• Furosemide
The dose of furosemide will be 1 mg/kg by intravenous bolus injection
• Saline
1 mg/kg by intravenous bolus injection

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac chamber volume loading.		4 hours after drug administration and 24 hours post recruitment	No
Secondary	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	No
Secondary	Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).		4 hours after drug administration and 24 hours post recruitment	No
Secondary	Changes in electrolyte balance, body weight and urine output.		4 hours after drug administration and 24 hours post recruitment	No