NCT03364842

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 22, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

28 days

First QC Date

November 21, 2017

Last Update Submit

December 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung ultrasonography scale > 24

    a 1 year study

Secondary Outcomes (1)

  • Pao2/ Fio2 ratio

    a 1 year study

Study Arms (2)

F group

EXPERIMENTAL

Furosemide group

Drug: Furosemide

C group

NO INTERVENTION

Control group

Interventions

Administering furosemide

F group

Eligibility Criteria

Age1 Month - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • coarctation of aorta

You may not qualify if:

  • heart failure, bleeding diathesis, associated cardiac congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 21, 2017

First Posted

December 7, 2017

Study Start

November 22, 2017

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

December 27, 2017

Record last verified: 2017-12

Locations