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.

Study Overview

• Status: Unknown
• Conditions: Lung Disease
• Intervention / Treatment: Drug: Furosemide; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Saline; 1 mg/kg by intravenous bolus injection
Experimental: 1; Furosemide	Drug: Furosemide; The dose of furosemide will be 1 mg/kg by intravenous bolus injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiac chamber volume loading.	4 hours after drug administration and 24 hours post recruitment

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement).	4 hours after drug administration and 24 hours post recruitment
Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).	4 hours after drug administration and 24 hours post recruitment
Changes in electrolyte balance, body weight and urine output.	4 hours after drug administration and 24 hours post recruitment

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Patrick McNamara, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): June 1, 2009

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): February 20, 2008
• Last Update Submitted That Met QC Criteria: February 19, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Pediatrics; Furosemide; Erythrocyte Transfusion; Fluid Overload
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: 1000009083