Lung DiseasePhase 3NCT00618852
Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
A Phase 3 study testing Furosemide and Saline in people with Lung Disease, run by The Hospital for Sick Children at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 44 weeks
- Conditions the study is for
- Lung Disease
- What is being tested?
- Furosemide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2007to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Edmond Kelley, MD, 416-586-5310, ekelly@mtsinai.on.ca
Edmond Kelley, MD
- Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Patrick McNamara, MD, 416 813 5773, patrick.mcnamara@sickkids.ca
Patrick McNamara, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Disease
- Being tested
- Furosemide, Saline
- Keywords
- Pediatrics, Erythrocyte Transfusion, Furosemide, Fluid Overload
- Medical subject headings
- Lung Diseases, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
The dose of furosemide will be 1 mg/kg by intravenous bolus injection
SalineDrug
1 mg/kg by intravenous bolus injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Furosemide Receives: Drug: Furosemide |
| 2 | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac chamber volume loading.
Measured: 4 hours after drug administration and 24 hours post recruitment
Secondary outcomes (3)
Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement).
Measured: 4 hours after drug administration and 24 hours post recruitment
Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).
Measured: 4 hours after drug administration and 24 hours post recruitment
Changes in electrolyte balance, body weight and urine output.
Measured: 4 hours after drug administration and 24 hours post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2008 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Investigators
- Patrick McNamara, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618852
- Sponsor's protocol ID
- 1000009083
- Status last verified
- Feb 2008
- First submitted
- 7 Feb 2008
- Last updated
- 20 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
- ClinicalTrials.gov ID
- NCT00618852
- Acronym / sponsor ID
- 1000009083
- Conditions
- Lung Disease
- Keywords
- Pediatrics, Erythrocyte Transfusion, Furosemide, Fluid Overload
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FurosemideFurosemide |
| 2 | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 1 week to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Less than 44 weeks corrected gestational age
- Receiving a red cell transfusion
- Satisfy one of the following criteria:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideThe dose of furosemide will be 1 mg/kg by intravenous bolus injection | Drug | 1 |
| Saline1 mg/kg by intravenous bolus injection | Drug | 2 |
Primary outcome
Cardiac chamber volume loading.
Time frame: 4 hours after drug administration and 24 hours post recruitment
3 secondary outcomes
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
Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).
Time frame: 4 hours after drug administration and 24 hours post recruitment
Changes in electrolyte balance, body weight and urine output.
Time frame: 4 hours after drug administration and 24 hours post recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick McNamara, MD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide and Saline in people with Lung Disease, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick McNamara, MD (416-813-5773, patrick.mcnamara@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac chamber volume loading. (time frame: 4 hours after drug administration and 24 hours post recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2008.