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

Primary Purpose

Lung Disease

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Furosemide
Saline
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Disease focused on measuring Pediatrics, Erythrocyte Transfusion, Furosemide, Fluid Overload

Eligibility Criteria

1 Week - 44 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai HospitalRecruiting
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Furosemide

Outcomes

Primary Outcome Measures

Cardiac chamber volume loading.

Secondary Outcome Measures

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.

Full Information

First Posted
February 7, 2008
Last Updated
February 19, 2008
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00618852
Brief Title
Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Official Title
A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
Pediatrics, Erythrocyte Transfusion, Furosemide, Fluid Overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Furosemide
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
The dose of furosemide will be 1 mg/kg by intravenous bolus injection
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
1 mg/kg by intravenous bolus injection
Primary Outcome Measure Information:
Title
Cardiac chamber volume loading.
Time Frame
4 hours after drug administration and 24 hours post recruitment
Secondary Outcome Measure Information:
Title
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
Title
Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).
Time Frame
4 hours after drug administration and 24 hours post recruitment
Title
Changes in electrolyte balance, body weight and urine output.
Time Frame
4 hours after drug administration and 24 hours post recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
44 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick McNamara, MD
Phone
416-813-5773
Email
patrick.mcnamara@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick McNamara, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edmond Kelley, MD
Phone
416-586-5310
Email
ekelly@mtsinai.on.ca
First Name & Middle Initial & Last Name & Degree
Edmond Kelley, MD
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick McNamara, MD
Phone
416 813 5773
Email
patrick.mcnamara@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Patrick McNamara, MD
First Name & Middle Initial & Last Name & Degree
Walid El-Naggar, MD
First Name & Middle Initial & Last Name & Degree
Anna Taddio, PhD

12. IPD Sharing Statement

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

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