Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
1 other identifier
observational
50
0 countries
N/A
Brief Summary
Background: PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care. Methods: A retrospective study included fifty children with isolated PDA treated by surgical ligation from June 2015 to June 2018. Their mean age was 15.78 ± 7.58 months and 72% were females. The LV dimensions and systolic function were assessed by two-dimensional echocardiography pre PDA ligation. The mean duct size was 4.08 ± 1.25 mm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedJuly 12, 2019
July 1, 2019
3.1 years
June 3, 2019
July 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison between the echocardiographic changes before PDA ligation to the follow up changes at one day, one month and six months post PDA ligation.
the echocardiographic data included: The LV end-diastolic dimension (LVEDd) in mm, LV end-systolic dimension (LVESd) in mm, PDA size in mm, left atrial to aortic diameter ratio (LA/Ao ratio), EF % and FS %
echocardiography was done before PDA ligation; and follow up at one day, one month and six months post ligation.
Secondary Outcomes (1)
identification of the preoperative predictor factors of LV dysfunction following PDA surgical ligation in children
all data were collected pre ligation; at one day, one month and six months post ligation
Eligibility Criteria
All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital.
You may qualify if:
- All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA.
You may not qualify if:
- Patients with silent PDA.
- irreversible pulmonary vascular disease.
- those who had associated hemodynamically significant congenital heart disease (CHD).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Abdel-Bary M, Abdel-Baseer KA, Abdel-Latif AF, Abdel-Naser MA, Nafie M, Eisa KM. Left ventricular dysfunction postsurgical patent ductus arteriosus ligation in children: predictor factors analysis. J Cardiothorac Surg. 2019 Sep 18;14(1):168. doi: 10.1186/s13019-019-0990-z.
PMID: 31533759DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 3, 2019
First Posted
July 12, 2019
Study Start
June 1, 2015
Primary Completion
June 30, 2018
Study Completion
October 30, 2018
Last Updated
July 12, 2019
Record last verified: 2019-07