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

NCT ID: NCT00618852

Last Updated: 2008-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Furosemide

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

The dose of furosemide will be 1 mg/kg by intravenous bolus injection

2

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

1 mg/kg by intravenous bolus injection

Interventions

Furosemide

The dose of furosemide will be 1 mg/kg by intravenous bolus injection

Intervention Type: DRUG

Saline

1 mg/kg by intravenous bolus injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 44 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

The Hospital for Sick Children

Principal Investigators

Patrick McNamara, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Patrick McNamara, MD

Role: CONTACT

patrick.mcnamara@sickkids.ca

416-813-5773

Facility Contacts

Edmond Kelley, MD

Role: primary

ekelly@mtsinai.on.ca

416-586-5310

Patrick McNamara, MD

Role: primary

patrick.mcnamara@sickkids.ca

416 813 5773

Other Identifiers

1000009083

Identifier Type: -

Identifier Source: org_study_id