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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.
| Condition or disease |
|---|
| Congenital Heart Disease in Children |
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 : | 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 |
- 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 %
- 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%.
| Ages Eligible for Study: | 8 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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).
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 3, 2019 | ||||
| First Posted Date | July 12, 2019 | ||||
| Last Update Posted Date | July 12, 2019 | ||||
| Actual Study Start Date | June 1, 2015 | ||||
| Actual Primary Completion Date | June 30, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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 %
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis | ||||
| Official Title | Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis | ||||
| 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. |
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| 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] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| Target Follow-Up Duration | 6 Months | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition | Congenital Heart Disease in Children | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
50 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | October 30, 2018 | ||||
| Actual Primary Completion Date | June 30, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 8 Months to 24 Months (Child) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04018079 | ||||
| Other Study ID Numbers | South Valley University 1513 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mohamed Abdel Bary Ahmed Ibrahim, South Valley University | ||||
| Study Sponsor | South Valley University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | South Valley University | ||||
| Verification Date | July 2019 | ||||
