ArrhythmiaPEDS-CARENCT06985082
This is an Observational Study That Aims to Demonstrate Postoperative Risk Factors in Pediatric Cardiac Surgery
An observational study of Arrhythmia and Acute Kidney Injuries, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial summary
This retrospective observational study aims to identify risk factors for postoperative complications in children undergoing cardiac surgery at a tertiary hospital in Brazil. By analyzing both electronic and physical medical records, researchers will examine demographic, clinical, surgical, and laboratory data… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Arrhythmia, Acute Kidney Injuries, Sepsis
- What is being tested?
- THERE IS NOT A INTERVENTION
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Children under 18 years of age undergoing elective or emergency pediatric cardiac surgeries, performed with or without extracorporeal circulation, will be included.
Who may be able to join
- All patients under 18 years of age who underwent cardiac surgery
Who cannot join
- Patients undergoing non-cardiac thoracic surgeries
- Patients over 18 years of age
- Pregnant women will be excluded from the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors for Postoperative Complications in Pediatric Cardiac Surgery: A Retrospective Observational Study
This retrospective observational study aims to identify risk factors for postoperative complications in children undergoing cardiac surgery at a tertiary hospital in Brazil. By analyzing both electronic and physical medical records, researchers will examine demographic, clinical, surgical, and laboratory data, focusing on variables such as cardiopulmonary bypass (CPB) time, use of vasoactive drugs, and the occurrence of complications such as arrhythmias, acute kidney injury, and infections. Statistical analysis will include both descriptive and inferential methods, with multivariate logistic regression used to identify predictors of adverse outcomes. The study will be conducted between 2025 and 2027 with an estimated budget of R$1,000. Its goal is to inform preventive strategies and optimize perioperative care, ultimately improving patient outcomes and reducing hospital costs.
Read the detailed description
Congenital heart disease (CHD) affects approximately 1% of births and, although surgical advances have significantly reduced mortality, postoperative complications still represent a major challenge. Cardiopulmonary bypass (CPB) has been associated with adverse outcomes, such as longer mechanical ventilation time, prolonged hospital stay and hospital infections, which reinforces the importance of identifying predictors of complications. In this context, this study seeks to analyze the main risk factors that influence the recovery of children undergoing cardiac surgeries, contributing to the improvement of perioperative management.
This is a retrospective observational study, which will be conducted based on the analysis of medical records of pediatric patients undergoing cardiac surgeries in a tertiary hospital in Brazil. The research will allow the evaluation of clinical, surgical and laboratory variables, aiming to identify patterns and associations between perioperative factors and postoperative complications. This approach is justified by the wide availability of data, allowing robust statistical analyses, in addition to enabling the identification of clinical trends relevant to medical practice.
The study's general objective is to identify risk factors for postoperative complications in pediatric cardiac surgeries. To this end, it seeks to evaluate the incidence and types of complications, analyze the relationship between extracorporeal circulation time and adverse outcomes, in addition to identifying perioperative variables associated with mortality, length of hospital stay and hospital costs.
Data collection will be performed retrospectively based on the analysis of electronic and physical medical records, ensuring patient confidentiality and anonymity. A standardized instrument will be used to extract information, covering demographic characteristics, preoperative information, intraoperative data, postoperative complications and clinical outcomes. Data collected include age, sex, weight, height, cardiac diagnosis, CPB time, and use of vasoactive drugs, in addition to the occurrence of complications such as arrhythmias, acute kidney injury, and hospital infections. Data storage and organization will follow strict security protocols, ensuring restricted access to the responsible researchers. The informed consent form will be waived.
Statistical analysis will be conducted using descriptive and inferential methods. Categorical variables will be expressed as frequencies and percentages, while continuous variables will be presented as means and standard deviations or medians and interquartile ranges, according to their distribution. Initially, comparisons between groups will be performed using appropriate statistical tests, such as the t-test, Mann-Whitney, chi-square, and Fisher's exact test. To identify predictive factors of postoperative complications, multivariate logistic regression will be applied, in addition to calculations of predictive performance, including ROC curve, sensitivity, and specificity. The results will be considered statistically significant for p < 0.05, and the analyses will be conducted using SPSS 25.0 and STATA 12.0 software.
The study will be conducted between 2025 and 2027, including submission to the Ethics Committee, data collection, statistical analysis and final defense. The total estimated budget for the research is R$ 1,000.00, covering costs for data collection materials, printing and acquisition of scientific literature.
Therefore, this study seeks to provide crucial information for reducing postoperative complications and optimizing care for pediatric patients undergoing cardiac surgeries. The identification of predictive factors will allow the development of preventive strategies and more effective interventions, contributing to improving the quality of life of these patients and reducing hospital costs.
- Conditions
- Arrhythmia, Acute Kidney Injuries, Sepsis, Pneumopathy, Thrombosis, Ventricular Asynchrony in Cardiac Surgery Patients
- Being tested
- THERE IS NOT A INTERVENTION
- Keywords
- Pediatric Cardiac Surgery, Risk Factors Postoperative, Complications Posoperative
- Medical subject headings
- Arrhythmias, Cardiac, Acute Kidney Injury, Sepsis, Lung Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERE IS NOT A INTERVENTIONOther
THERE IS NOT A INTERVENTION
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors
To identify risk factors associated with postoperative complications in pediatric cardiac surgeries performed in a tertiary hospital in Brazil.
Measured: 2 years
Secondary outcomes (4)
The Incidence
To assess the incidence and types of cardiac and extracardiac complications after pediatric cardiac surgery.
Measured: 2 years
CPB and Complications
Analyze the relationship between duration of extracorporeal circulation and postoperative complications.
Measured: 2 years
Adverse Outcomes
Identify perioperative risk factors associated with adverse outcomes
Measured: 2 years
The influence of complications
Analyze how postoperative complications influence length of hospital stay, mortality and hospital costs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Kirschen Bristot, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985082
- Sponsor's protocol ID
- 6166.25
- Acronym
- PEDS-CARE
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Complications in Pediatric Cardiac Surgery: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06985082
- Acronym / sponsor ID
- PEDS-CARE / 6166.25
- Conditions
- Arrhythmia, Acute Kidney Injuries, Sepsis, Pneumopathy, Thrombosis, Ventricular Asynchrony in Cardiac Surgery Patients
- Keywords
- Pediatric Cardiac Surgery, Risk Factors Postoperative, Complications Posoperative
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational study aims to identify risk factors for postoperative complications in children undergoing cardiac surgery at a tertiary hospital in Brazil. By analyzing both electronic and physical medical records, researchers will examine demographic, clinical, surgical, and laboratory data, focusing on variables such as cardiopulmonary bypass (CPB) time, use of vasoactive drugs, and the occurrence of complications such as arrhythmias, acute kidney injury, and infections. Statistical analysis will include both descriptive and inferential methods, with multivariate logistic regression used to identify predictors of adverse outcomes. The study will be conducted between 2025 and 2027 with an estimated budget of R$1,000. Its goal is to inform preventive strategies and optimize perioperative care, ultimately improving patient outcomes and reducing hospital costs.
Detailed description
Congenital heart disease (CHD) affects approximately 1% of births and, although surgical advances have significantly reduced mortality, postoperative complications still represent a major challenge. Cardiopulmonary bypass (CPB) has been associated with adverse outcomes, such as longer mechanical ventilation time, prolonged hospital stay and hospital infections, which reinforces the importance of identifying predictors of complications. In this context, this study seeks to analyze the main risk factors that influence the recovery of children undergoing cardiac surgeries, contributing to the improvement of perioperative management.
This is a retrospective observational study, which will be conducted based on the analysis of medical records of pediatric patients undergoing cardiac surgeries in a tertiary hospital in Brazil. The research will allow the evaluation of clinical, surgical and laboratory variables, aiming to identify patterns and associations between perioperative factors and postoperative complications. This approach is justified by the wide availability of data, allowing robust statistical analyses, in addition to enabling the identification of clinical trends relevant to medical practice.
The study's general objective is to identify risk factors for postoperative complications in pediatric cardiac surgeries. To this end, it seeks to evaluate the incidence and types of complications, analyze the relationship between extracorporeal circulation time and adverse outcomes, in addition to identifying perioperative variables associated with mortality, length of hospital stay and hospital costs.
Data collection will be performed retrospectively based on the analysis of electronic and physical medical records, ensuring patient confidentiality and anonymity. A standardized instrument will be used to extract information, covering demographic characteristics, preoperative information, intraoperative data, postoperative complications and clinical outcomes. Data collected include age, sex, weight, height, cardiac diagnosis, CPB time, and use of vasoactive drugs, in addition to the occurrence of complications such as arrhythmias, acute kidney injury, and hospital infections. Data storage and organization will follow strict security protocols, ensuring restricted access to the responsible researchers. The informed consent form will be waived.
Statistical analysis will be conducted using descriptive and inferential methods. Categorical variables will be expressed as frequencies and percentages, while continuous variables will be presented as means and standard deviations or medians and interquartile ranges, according to their distribution. Initially, comparisons between groups will be performed using appropriate statistical tests, such as the t-test, Mann-Whitney, chi-square, and Fisher's exact test. To identify predictive factors of postoperative complications, multivariate logistic regression will be applied, in addition to calculations of predictive performance, including ROC curve, sensitivity, and specificity. The results will be considered statistically significant for p < 0.05, and the analyses will be conducted using SPSS 25.0 and STATA 12.0 software.
The study will be conducted between 2025 and 2027, including submission to the Ethics Committee, data collection, statistical analysis and final defense. The total estimated budget for the research is R$ 1,000.00, covering costs for data collection materials, printing and acquisition of scientific literature.
Therefore, this study seeks to provide crucial information for reducing postoperative complications and optimizing care for pediatric patients undergoing cardiac surgeries. The identification of predictive factors will allow the development of preventive strategies and more effective interventions, contributing to improving the quality of life of these patients and reducing hospital costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children under 18 years of age undergoing elective or emergency pediatric cardiac surgeries, performed with or without extracorporeal circulation, will be included.
Key inclusion criteria (1 listed)
- All patients under 18 years of age who underwent cardiac surgery
Key exclusion criteria (3 listed)
- Patients undergoing non-cardiac thoracic surgeries
- Patients over 18 years of age
- Pregnant women will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERE IS NOT A INTERVENTIONTHERE IS NOT A INTERVENTION | Other | – |
Primary outcome
Risk Factors
Time frame: 2 years
To identify risk factors associated with postoperative complications in pediatric cardiac surgeries performed in a tertiary hospital in Brazil.
4 secondary outcomes
The Incidence
Time frame: 2 years
CPB and Complications
Time frame: 2 years
Adverse Outcomes
Time frame: 2 years
The influence of complications
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Acute Kidney Injuries, run by Instituto de Cardiologia do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Bristot, Lead researcher (+555199947-3379, carolinekbristot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.