Pulmonary ComplicationPhase 2NCT03364842
Furosemide and Coarctation Surgery Lung Complications
A Phase 2 study testing Furosemide in people with Pulmonary Complication, run by Cairo University at 1 site in Egypt.
Trial summary
in our study the investigators give furosemide during surgery for repair of aortic coarctation via lateral thoracotomy and evaluated lung complications in comparison to control group Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Pulmonary Complication
- What is being tested?
- Furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2017to 20 Dec 2017
- Phase
- Phase 2
- 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 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- coarctation of aorta
Who cannot join
- heart failure, bleeding diathesis, associated cardiac congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Furosemide: Would it Help to Improve the Lungs During Aortic Coarctation Surgery
in our study the investigators give furosemide during surgery for repair of aortic coarctation via lateral thoracotomy and evaluated lung complications in comparison to control group
- Conditions
- Pulmonary Complication
- Being tested
- Furosemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Administering furosemide
| Study group | Role | What they receive |
|---|---|---|
| F group | Experimental | Furosemide group Receives: Drug: Furosemide |
| C group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasonography scale > 24
Measured: a 1 year study
Secondary outcomes (1)
Pao2/ Fio2 ratio
Measured: a 1 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start22 Nov 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kareem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364842
- Sponsor's protocol ID
- Fuurosemide and coarctation
- Status last verified
- Dec 2017
- First submitted
- 21 Nov 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide: Would it Help to Improve the Lungs During Aortic Coarctation Surgery
- ClinicalTrials.gov ID
- NCT03364842
- Acronym / sponsor ID
- Fuurosemide and coarctation
- Conditions
- Pulmonary Complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 7 Dec 2017 (actual)
- 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.
in our study the investigators give furosemide during surgery for repair of aortic coarctation via lateral thoracotomy and evaluated lung complications in comparison to control group
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F group | Experimental | Drug: FurosemideFurosemide group |
| C group | No intervention | –Control group |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- coarctation of aorta
Key exclusion criteria (1 listed)
- heart failure, bleeding diathesis, associated cardiac congenital anomalies
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 |
|---|---|---|
| FurosemideAdministering furosemide | Drug | F group |
Primary outcome
lung ultrasonography scale > 24
Time frame: a 1 year study
1 secondary outcome
Pao2/ Fio2 ratio
Time frame: a 1 year study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furosemide in people with Pulmonary Complication, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung ultrasonography scale > 24 (time frame: a 1 year study). 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 27 Dec 2017.