Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Disease
Intervention: Furosemide (Drug); Saline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Patrick McNamara, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
Overall contact:
Patrick McNamara, MD, Phone: 416-813-5773, Email: patrick.mcnamara@sickkids.ca
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.
Clinical Details
Official title: A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Cardiac chamber volume loading.
Secondary outcome: Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement).Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam). Changes in electrolyte balance, body weight and urine output.
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
Minimum age: N/A.
Maximum age: 44 Weeks.
Gender(s): Both.
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
Locations and Contacts
Patrick McNamara, MD, Phone: 416-813-5773, Email: patrick.mcnamara@sickkids.ca
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Not yet recruiting
Patrick McNamara, MD, Phone: 416 813 5773, Email: patrick.mcnamara@sickkids.ca
Patrick McNamara, MD, Principal Investigator
Walid El-Naggar, MD, Sub-Investigator
Anna Taddio, PhD, Sub-Investigator
Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; Recruiting
Edmond Kelley, MD, Phone: 416-586-5310, Email: ekelly@mtsinai.on.ca
Edmond Kelley, MD, Principal Investigator
Additional Information
Starting date: January 2007
Ending date: June 2009
Last updated: February 19, 2008
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