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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00618852
First received: February 7, 2008
Last updated: February 19, 2008
Last verified: February 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

Resource links provided by NLM:


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
Experimental: 1
Furosemide
Drug: Furosemide
The dose of furosemide will be 1 mg/kg by intravenous bolus injection
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Patrick McNamara, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

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

Keywords provided by The Hospital for Sick Children:
Pediatrics
Erythrocyte Transfusion
Furosemide
Fluid Overload

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Furosemide
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014