Back to resultsFurosemide and Coarctation Surgery Lung Complications
Primary Purpose
Pulmonary Complication
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Furosemide
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Complication
Eligibility Criteria
Inclusion Criteria:
- coarctation of aorta
Exclusion Criteria:
- heart failure, bleeding diathesis, associated cardiac congenital anomalies
Sites / Locations
- Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
F group
C group
Arm Description
Furosemide group
Control group
Outcomes
Primary Outcome Measures
lung ultrasonography scale > 24
Secondary Outcome Measures
Pao2/ Fio2 ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03364842
Brief Title
Furosemide and Coarctation Surgery Lung Complications
Official Title
Furosemide: Would it Help to Improve the Lungs During Aortic Coarctation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Complication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F group
Arm Type
Experimental
Arm Description
Furosemide group
Arm Title
C group
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
Administering furosemide
Primary Outcome Measure Information:
Title
lung ultrasonography scale > 24
Time Frame
a 1 year study
Secondary Outcome Measure Information:
Title
Pao2/ Fio2 ratio
Time Frame
a 1 year study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coarctation of aorta
Exclusion Criteria:
heart failure, bleeding diathesis, associated cardiac congenital anomalies
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Furosemide and Coarctation Surgery Lung Complications
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