TrialX
Image

Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Recruiting
16 years and younger
All
Phase N/A

Overview

Recent studies show an important influence of gender on inflammatory reactions. Cardiac surgery is associated with a major systemic inflammatory response. The investigators want to evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.

Description

Gender plays an important role in the inflammatory response. This is due to hormonal influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass, is associated with a major inflammatory response. This response is even more marked in pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. The investigators will do a retrospective cohort study, analysing the local database of all paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any difference in mortality and /or major morbidity according to gender.

Statistical analysis:

The investigators will use a propensity score on 11 pre-operative variables clinically judged relevant. Both group will be matched until a absolute standardised difference < 15% is obtained. This type of matching, contrary to a P value, is independent of sample size. Variables will be presented as mean, standard deviation or percentage for frequency distributions. After propensity score matching, logistic regressions will be performed on binary variables and linear regressions on continuous variables. A Bonferroni correction will be used for multiple comparisons.

Eligibility

Inclusion Criteria:

  • All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Jehova's witness

Study details
    Gender
    Pediatric Cardiac Surgery

NCT04452539

Brugmann University Hospital

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.