Full Text View
Tabular View
No Study Results Posted
Related Studies
Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
This study is currently recruiting participants.
Study NCT00618852   Information provided by The Hospital for Sick Children
First Received: February 7, 2008   Last Updated: February 19, 2008   History of Changes

February 7, 2008
February 19, 2008
January 2007
December 2008   (final data collection date for primary outcome measure)
Cardiac chamber volume loading. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00618852 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Lung Disease
  • Drug: Furosemide
  • Drug: Saline
Experimental: Furosemide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
64
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
up to 44 Weeks
No
Contact: Patrick McNamara, MD 416-813-5773 patrick.mcnamara@sickkids.ca
Canada
 
NCT00618852
Patrick McNamara/Principal Investigator, The Hospital for Sick Children
1000009083
The Hospital for Sick Children
 
Principal Investigator: Patrick McNamara, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP