NCT04452539

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

June 26, 2020

Last Update Submit

January 27, 2021

Conditions

Pediatric Cardiac SurgeryGender

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Mortality in paediatric cardiac surgery

    Beginning of the operation until 5 days postop

  • Morbidity

    Major morbidity in paediatric cardiac surgery, defined as at least 2 of the following conditions: Respiratory failure (mechanical ventilation \> 90h), prolonged inotropic support (\> 5 mcg/kg/min of dobutamine for more than 48h postop), renal insufficiency (Drop in glomerular filtration rate \> 75% compared to preop values)

    Beginning of the operation until 5 days postop

Study Arms (1)

Paediatric cardiac surgery patients

All patients undergoing paediatric cardiac surgery

Procedure: Paediatric cardiac surgery

Interventions

Paediatric cardiac surgeryPROCEDURE

All patients undergoing paediatric cardiac surgery

Paediatric cardiac surgery patients

Eligibility Criteria

AgeUp to 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing paediatric cardiac surgery with cardiopulmonary bypas at our institution from jan 2006 to dec 2019.

You may qualify if:

  • All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • Jehova's witness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Denis Schmartz, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Anesthesiology

Study Record Dates

First Submitted

June 26, 2020

First Posted

June 30, 2020

Study Start

July 2, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)