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

NCT06985082 | Not Yet Recruiting

• 1 other identifier: 6166.25
• Study Type: observational
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Risk Factors

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

  2 years

Secondary Outcomes (4)

• The Incidence

  2 years

• CPB and Complications

  2 years

• Adverse Outcomes

  2 years

• The influence of complications

  2 years

Interventions

THERE IS NOT A INTERVENTION OTHER

THERE IS NOT A INTERVENTION

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac; Acute Kidney Injury; Sepsis; Lung Diseases; Thrombosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases

Central Study Contacts

Caroline Bristot, Lead researcher

CONTACT

+555199947-3379; carolinekbristot@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 22, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05