Influence of Inotropic Choice on Morbidity and Mortality in Complex Pediatric Heart Surgery

NCT04380181 | Completed

• 1 other identifier: CHUB-ped_CS_inotropes
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cardiac Surgery

Keywords

pediatric cardiopulmonary bypass; milrinone; dobutamine; epinephrine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dobutamine

Weaning from cardiopulmonary bypass using dobutamine as inotrope.

Drug: dobu

Milrinone-epinephrine

Weaning from cardiopulmonary bypass using milrinone and epinephrine as inotropes.

Interventions

dobu DRUG

Use of dobutamine versus milrinone and epinephrine for separation from cardiopulmonary bypass

Also known as: milrinone-epinephrine

Dobutamine

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under 1 year undergoing complex cardiac surgery with cardiopulmonary bypass

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Brugmann University Hospital: lead
• Queen Fabiola Children's University Hospital: collaborator

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: May 11, 2020
• Primary Completion: June 5, 2020
• Study Completion: June 10, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)