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Not yet recruitingNCT06985082PEDS-CAREUpdated May 22, 2025

This is an Observational Study That Aims to Demonstrate Postoperative Risk Factors in Pediatric Cardiac Surgery

An observational study in Arrhythmia, Acute Kidney Injuries and Sepsis, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Not yet recruiting. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
310
Ages
Up to 18 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Arrhythmia
  • Acute Kidney Injuries
  • Sepsis
  • Pneumopathy
  • Thrombosis
  • Ventricular Asynchrony in Cardiac Surgery Patients
  • Pediatric Cardiac Surgery

Keywords

  • Pediatric Cardiac Surgery
  • Risk Factors Postoperative
  • Complications Posoperative
03

In context

Arrhythmias, Cardiac

1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

This study's planned enrollment of 310 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 76 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Children under 18 years of age undergoing elective or emergency pediatric cardiac surgeries, performed with or without extracorporeal circulation, will be included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients under 18 years of age who underwent cardiac surgery

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing non-cardiac thoracic surgeries
  • Patients over 18 years of age
  • Pregnant women will be excluded from the study
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
310 participants (estimated)
Patient registry
No

Interventions

  • OtherTHERE IS NOT A INTERVENTION

    THERE IS NOT A INTERVENTION

06

What researchers measure

Primary outcomes

  1. Risk Factors

    To identify risk factors associated with postoperative complications in pediatric cardiac surgeries performed in a tertiary hospital in Brazil.

    Time frame: 2 years

Secondary outcomes

  1. The Incidence

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

    Time frame: 2 years

  2. CPB and Complications

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

    Time frame: 2 years

  3. Adverse Outcomes

    Identify perioperative risk factors associated with adverse outcomes

    Time frame: 2 years

  4. The influence of complications

    Analyze how postoperative complications influence length of hospital stay, mortality and hospital costs

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for May 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2025
First posted
May 22, 2025
StartEst.
May 2025
Primary completionEst.
May 2025
CompletionEst.
Aug 2025
Last update
May 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06985082
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible party
Caroline Kirschen Bristot (Anesthesiologist, Instituto de Cardiologia do Rio Grande do Sul) — Principal investigator
First posted
May 22, 2025
Start date
May 2025 (estimated)
Primary completion
May 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
May 22, 2025

Study contacts

Caroline Bristot, Lead researcher
Contact
carolinekbristot@gmail.com
+555199947-3379

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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