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

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

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

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

Additional Information

Starting date: January 2007
Last updated: February 19, 2008

Page last updated: August 23, 2015

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