- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364842
Furosemide and Coarctation Surgery Lung Complications
December 22, 2017 updated by: Ahmed Kareem, Cairo University
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Cairo, Egypt
- Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- coarctation of aorta
Exclusion Criteria:
- heart failure, bleeding diathesis, associated cardiac congenital anomalies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: F group
Furosemide group
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Administering furosemide
|
No Intervention: C group
Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lung ultrasonography scale > 24
Time Frame: a 1 year study
|
a 1 year study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pao2/ Fio2 ratio
Time Frame: a 1 year study
|
a 1 year study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2017
Primary Completion (Actual)
December 20, 2017
Study Completion (Actual)
December 20, 2017
Study Registration Dates
First Submitted
November 21, 2017
First Submitted That Met QC Criteria
December 1, 2017
First Posted (Actual)
December 7, 2017
Study Record Updates
Last Update Posted (Actual)
December 27, 2017
Last Update Submitted That Met QC Criteria
December 22, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Aortic Coarctation
- 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
- Fuurosemide and coarctation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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