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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Caroline Bristot, Lead researcher contact

+555199947-3379

carolinekbristot@gmail.com

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.

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.

  1. 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)
  1. The Incidence

    To assess the incidence and types of cardiac and extracardiac complications after pediatric cardiac surgery.

    Measured: 2 years

  2. CPB and Complications

    Analyze the relationship between duration of extracorporeal circulation and postoperative complications.

    Measured: 2 years

  3. Adverse Outcomes

    Identify perioperative risk factors associated with adverse outcomes

    Measured: 2 years

  4. 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.

  1. First posted22 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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)
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

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.

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