- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018079
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
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.
Study Overview
Status
Conditions
Detailed Description
Methods:
Study population Fifty children with PDA, for whom surgical PDA ligation was done from June 2015 to June 2018. All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital. Their mean age at intervention was 15.78 ± 7.58 months, body surface area (BSA) 0.43±0.03 and 32 (72%) were females. The mean duct diameter was 4.08 ± 1.25 mm. The study conforms to the ethical standards of the Helsinki Declaration and approval was obtained from the institutional ethics committee of Qena Faculty of Medicine.
Surgical technique PDA ligation was performed under general anaesthesia after pre-operative anaesthetic evaluation. After single endotracheal tube anaesthesia induction; children were placed on the right lateral recumbent position fixed with adhesive plaster and a pad under the chest, the left arm raised above the head. A left mini-thoracotomy incision is done parallel to the medial border of the scapula and entrance to the thoracic cavity was via the third or fourth intercostal space. Cautiously, the ductus is identified and dissected carefully. Then it was doubly ligated with silk ligature (2/0 or 0). An intercostal tube inserted during operation and removed within 48 hours if no drainage presents.
Descriptive statistical analysis Data were arranged and analyzed utilizing Version 20 of the SPSS program (Statistical Package for Social Sciences). Continuous variables were compared using the Student paired t-test and are expressed as mean values ± standard deviation. Pearson Chi-Square tests were used to detect differences among groups for categorical variables. The relationship between PDA size and changes in echocardiographic parameters was verified using the Pearson linear correlation and the linear regression analysis. P-value of <0.05 was considered of significance.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA.
Exclusion Criteria:
- Patients with silent PDA.
- irreversible pulmonary vascular disease.
- those who had associated hemodynamically significant congenital heart disease (CHD).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison between the echocardiographic changes before PDA ligation to the follow up changes at one day, one month and six months post PDA ligation.
Time Frame: echocardiography was done before PDA ligation; and follow up at one day, one month and six months post 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
identification of the preoperative predictor factors of LV dysfunction following PDA surgical ligation in children
Time Frame: all data were collected pre ligation; at one day, one month and six months post ligation
|
we classified our patients into two gatherings as indicated by FS % based on a definition of LV systolic dysfunction; group I with FS ≤ 29% and group II with FS > 29%.
|
all data were collected pre ligation; at one day, one month and six months post ligation
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- South Valley University 1513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Congenital Heart Disease in Children
-
Children's Mercy Hospital Kansas CityChildren's Hospital of Philadelphia; University of North Carolina, Chapel Hill and other collaboratorsRecruitingCongenital Heart Disease in ChildrenUnited States
-
HealthCore-NERIPediatric Heart NetworkRecruitingCongenital Heart Disease in ChildrenUnited States, Canada
-
University Hospital, Strasbourg, FranceRecruitingCongenital Heart Disease in ChildrenFrance
-
University Children's Hospital, ZurichCompletedCongenital Heart Disease in ChildrenSwitzerland
-
Johns Hopkins UniversityRecruitingCongenital Heart Disease in ChildrenUnited States
-
Assiut UniversityNot yet recruitingCommon Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical AuditCongenital Heart Disease in Children
-
Xinhua Hospital, Shanghai Jiao Tong University...RecruitingCongenital Heart Disease in ChildrenChina
-
Queen Fabiola Children's University HospitalTerminatedCongenital Heart Disease in ChildrenBelgium
-
Boston Children's HospitalThe Hospital for Sick Children; Baylor College of Medicine; Children's Hospital... and other collaboratorsRecruitingCongenital Heart Disease in ChildrenUnited States, Canada
-
University Hospital, Strasbourg, FranceCompletedCongenital Heart Disease in ChildrenFrance