Early postoperative arrhythmias after pediatric cardiac surgery
| ISRCTN | ISRCTN56860224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56860224 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 20/01/2023
- Registration date
- 14/02/2023
- Last edited
- 14/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Early postoperative arrhythmias are a known complication of cardiac surgery; however, little data exists on pediatric patients. This prospective study was proposed to determine the incidence, and risk factors for early postoperative arrhythmias after pediatric cardiac surgery.
Who can participate?
Pediatric patients who underwent cardiac surgery at Damascus University Pediatric Hospital between July 2020 and July 2021
What does the study involve?
All patients will be evaluated for their entire stay in the intensive care unit, from postoperative admission to discharge from the pediatric intensive care unit.
What are the possible benefits and risks of participating?
By determining the risk factors for early postoperative arrhythmias, we will prevent these arrhythmias and influence the long-term survival of patients with congenital heart diseases. There are no risks of participating.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2020 to November 2021
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Rahaf Ibrahim, dr.r.e345@gmail.com
Contact information
Principal investigator
Pediatric Department
Damascus University Pediatric Hospital
Damascus
None available
Syria
 ORCID ID |
0000-0001-7216-2250 |
|---|---|
| Phone | +963934518980 |
| dr.r.e345@gmail.com |
Scientific
Pediatric Department
Damascus University Pediatric Hospital
Damascus
None available
Syria
| Phone | +963934518980 |
|---|---|
| dr.r.e345@gmail.com |
Public
Pediatric Department
Damascus University Pediatric Hospital
Damascus
None available
Syria
| Phone | +963934518980 |
|---|---|
| dr.r.e345@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Early postoperative arrhythmias after pediatric cardiac surgery: a cohort prospective study |
| Study objectives | This prospective study was proposed to determine the incidence, and risk factors for early postoperative arrhythmias after pediatric cardiac surgery |
| Ethics approval(s) | Approved 11/06/2020, ethics committee of Damascus University (Damascus University; +963112123664; deansoffice.medicine@gmail.com), ref: none available |
| Health condition(s) or problem(s) studied | Early postoperative arrhythmias after pediatric cardiac surgery |
| Intervention | All patients are evaluated prospectively during their entire stay in the intensive care unit, from postoperative admission to discharge from the pediatric intensive care unit (PICU). Postoperative care will be in the PICU, with management provided by members of pediatric cardiology, pediatric critical care, and pediatric cardiac surgery staff. All the ECG records are assessed by the same pediatric cardiologist. Standard electrocardiograms (ECGs) are registered in all patients at the time of PICU admission. Continuous ECG monitoring is performed using bedside monitors during the entire PICU stay. |
| Intervention type | Other |
| Primary outcome measure(s) |
Arrhythmias measured using bedside monitors during the entire pediatric intensive care unit stay |
| Key secondary outcome measure(s) |
Risk factors for early postoperative arrhythmias after pediatric cardiac surgery measured using the information in the patients' medical files over the entire pediatric intensive care unit stay |
| Completion date | 15/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 229 |
| Key inclusion criteria | 1. Children who had undergone cardiac surgery for corrections of congenital cardiac disease were enrolled in this study 2. Patients included were aged 14 years at most 3. Patients included had a complete medical file |
| Key exclusion criteria | 1. Surgery without cardiopulmonary bypass time 2. Patient age 15 years or older at the time of surgery 3. History of chronic arrhythmias |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 01/07/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus University Pediatric Hospital
Damascus
None available
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rahaf Ibrahim, dr.r.e345@gmail.com. Participants' data will be available upon request. The date when data will be available is when these data are requested. Consent was obtained from the participant’s parents. These data will be anonymized. There are no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2023: Trial's existence confirmed by Damascus University.
