SIRS in Cyanotic and Acyanotic Children in Cardiac Surgery

NCT04254744 | Completed FDA Drug

• 1 other identifier: SIRS, cardiac surgery
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic inflammatory response syndrome (SIRS) is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.

Conditions

SIRS; Pediatric Cardiac Surgery

Outcome Measures

Primary Outcomes (3)

• White blood cell count

  48 hours after arrival in Intensive care unit

• body temperature

  48 hours after arrival in Intensive care unit

• heart rate

  48 hours after arrival in Intensive care unit

Study Arms (2)

Acyanotic children

Acyanotic children undergoing cardiac surgery due to congenital heart disease

Drug: Sevoflurane

Cyanotic children

Cyanotic children undergoing cardiac surgery due to congenital heart disease

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

Sevoflurane inhalation for anesthesia

Acyanotic children; Cyanotic children

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients with congenital heart disease

You may qualify if:

• Patients aged between 0-16 years
• undergoing open heart surgery for cyanotic and acyanotic congenital heart disease

You may not qualify if:

• Patients with preoperative renal failure
• Patients with preoperative hepatic disease
• Patients with preoperative inflammatory disease
• Patients using anti-inflammatory drug

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: February 5, 2020
• Study Start: February 4, 2020
• Primary Completion: January 4, 2021
• Study Completion: February 4, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)