Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis

Congenital Heart Disease in Children Clinical Trial

Official title:

Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018079
• Other study ID #: South Valley University 1513
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2019
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 24 Months

Eligibility

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).

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Ductus Arteriosus, Patent
• Heart Diseases
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	identification of the preoperative predictor factors of LV dysfunction following PDA surgical ligation in children	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