Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00618852

Purpose

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.

Condition	Intervention	Phase
Lung Disease	Drug: Furosemide Drug: Saline	Phase III

MedlinePlus related topics: Blood Transfusion and Donation

Drug Information available for: Furosemide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Cardiac chamber volume loading. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement). [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ] [ Designated as safety issue: No ]
Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam). [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ] [ Designated as safety issue: No ]
Changes in electrolyte balance, body weight and urine output. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Furosemide	Drug: Furosemide The dose of furosemide will be 1 mg/kg by intravenous bolus injection
2: Placebo Comparator	Drug: Saline 1 mg/kg by intravenous bolus injection

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

Ages Eligible for Study:	up to 44 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618852

Contacts

Contact: Patrick McNamara, MD

416-813-5773

patrick.mcnamara@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Patrick McNamara, MD 416 813 5773 patrick.mcnamara@sickkids.ca
Principal Investigator: Patrick McNamara, MD
Sub-Investigator: Walid El-Naggar, MD
Sub-Investigator: Anna Taddio, PhD
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Edmond Kelley, MD 416-586-5310 ekelly@mtsinai.on.ca
Principal Investigator: Edmond Kelley, MD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Patrick McNamara, MD

The Hospital for Sick Children, Toronto Canada

More Information

Responsible Party:	The Hospital for Sick Children ( Patrick McNamara/Principal Investigator )
Study ID Numbers:	1000009083
Study First Received:	February 7, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00618852
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Pediatrics
Erythrocyte Transfusion
Furosemide
Fluid Overload

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Furosemide

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Diuretics
Cardiovascular Agents
Sodium Potassium Chloride Symporter Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009