Pediatric Cardiac Surgery Clinical Trial
— CHUBpedCSinoOfficial title:
Does the Choice of Perioperative Inotropes Has Influence on the Morbidity and Mortality of Infants Operated for Complex Heart Defects?
Verified date | June 2020 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Our study is based on the observation that management of the cardiopulmonary by-pass
withdrawal in pediatric heart surgery is quite variable between medical teams.
Indeed, in our center (HUDERF), the most common inotropic plan is dobutamine only or
combination of milrinone and adrenalin but their uses seem to be very anesthesiologist
dependent.
Despite the lack of sufficient evidence, the choice is probably multi-factorial, based mainly
on the inotrope pharmacology, the patient physiopathology and the anesthesiologist
preference.
The aim of this study is to determine if one of these inotropic strategy (dobutamine VS
milrinone + adrenaline) is better compared to the other in terms of morbi-mortality.
In order to do that, the investigators will realize a retrospective study based on files from
January 2008 to December 2018 concerning 250 selected patients.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 10, 2020 |
Est. primary completion date | June 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Year |
Eligibility |
Inclusion Criteria: Patient under 1 year old. Cardiac surgery with CPB between 2008-2018. RACHS-1 risk categories >3. We selected the most relevant and common surgery in our center: - Transposition of the great arteries - Atrio-ventricular canal defect - Aortic coarctation or interruption - Truncus arteriosus - Mitral valvuloplasty Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital | Queen Fabiola Children's University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MODS2 score | Impact of the inotropic plan on the morbi-mortality. Use of the MODS2 score who is defined by death or 2 organ's failures: circulation, respiratory or renal | Weaning from cardiopulmonary bypass in the operating room |
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