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

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ClinicalTrials.gov Identifier: NCT04018079
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdel Bary Ahmed Ibrahim, South Valley University

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.


Condition or disease
Congenital Heart Disease in Children

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 6 Months
Official Title: Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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. [ 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 %


Secondary Outcome Measures :
  1. 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%.



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Ages Eligible for Study:   8 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital.
Criteria

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).

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Responsible Party: Mohamed Abdel Bary Ahmed Ibrahim, Associate professor, South Valley University
ClinicalTrials.gov Identifier: NCT04018079     History of Changes
Other Study ID Numbers: South Valley University 1513
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Abdel Bary Ahmed Ibrahim, South Valley University:
PDA
Echo

Additional relevant MeSH terms:
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Heart Diseases
Ventricular Dysfunction
Ductus Arteriosus, Patent
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities