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Pediatric Cardiac SurgeryCHUBpedCSinoNCT04380181

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

An observational study of Pediatric Cardiac Surgery, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 1 year
Conditions the study is for
Pediatric Cardiac Surgery
What is being tested?
dobu
How many people
250 participants
Where
1 siteBelgium
Study dates
11 May 2020to 10 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 1 year
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children under 1 year undergoing complex cardiac surgery with cardiopulmonary bypass

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussels, 1020

Other trials in Belgium

About this study

Official title: Does the Choice of Perioperative Inotropes Has Influence on the Morbidity and Mortality of Infants Operated for Complex Heart Defects?

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.

Read more

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.

Read the detailed description

As use of inotropes is highly variable between anesthesiologists, the investigators want to study if the choice of the inotropic drugs have an impact on morbid-mortality in paediatric cardiac surgery.

The investigators will retrospectively review the files from patients operated from january 2008 to December 2018. The investigators will concentrate on high risk patients defined as age ≤ 1 year, RACHS score ≥ 3 and complex heart surgery (Switch procedure, atrioventricular canal defect, aortic coarctation or aortic arch interruption, truncus arteriosus, mitral valvuloplasty). The investigators aim for a study population of about 250 patients. Primary outcome will be MODS score defined by death or 2 organ dysfunction (circulatory, respiratory or renal failure).

Statistical analysis:

One propensity score will be performed on two groups: Dobu and Milri. After 15 multiple imputations of the datasets using the mice R package, the CBPS R package will be used to perform the propensity score, estimating an Average Treatment Effect (ATE), using covariate balancing and requesting an exact match, which has been showed to be superior to traditional logistic regression approaches and boosted classification and regression trees . An absolute standardized difference less than 10-15% will be considered to support the assumption of balance between the groups because it is not affected by the sample size, unlike P-values, and it may be used to compare the relative balance of variables measured in different units. The mean and standard deviation obtained after matching for continuous variables, and the percentage for categorical variables will be presented. After the propensity score, the investigators will use the survey R package to perform logistic regressions for binary outcome variables and linear regressions for continuous outcomes, which will include the treatment group effect, the weight resulting from the matching and variables present in the propensity score in order to obtain a doubly-robust estimator which will correct the last remaining possible imbalance between the covariates and produces an unbiased treatment effect. The survey R package includes the Huber-White corrected standard errors, which maintains the standard errors unbiased even under heterogeneity of the residuals. Last, the advantage of a doubly-robust estimator is that it needs only one of the two models (propensity score and logistic regression after the propensity score) to be correctly specified. The so-called 'within approach', that is averaging the treatment effects on the 15 logistic and linear regressions has been showed to produce less biased estimates than the 'Across approach' - that is, performing linear or logistic regressions on averaged imputed matched datasets - especially when missing data is related to the treatment group. The R software (R Core Team, 2019), version 3.6.2. will be used to produce the results.

Being tested
dobu
Keywords
pediatric cardiopulmonary bypass, milrinone, dobutamine, epinephrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dobuDrug

    Also called milrinone-epinephrine

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

Study groups in NCT04380181
Study groupRoleWhat they receive
DobutamineWeaning from cardiopulmonary bypass using dobutamine as inotrope.
Receives: Drug: dobu
Milrinone-epinephrineWeaning from cardiopulmonary bypass using milrinone and epinephrine as inotropes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Weaning from cardiopulmonary bypass in the operating room

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start11 May 2020
  3. Primary completion5 Jun 2020
  4. Study completion10 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380181
Sponsor's protocol ID
CHUB-ped_CS_inotropes
Acronym
CHUBpedCSino
Status last verified
Jun 2020
First submitted
5 May 2020
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Cardiac Surgery, run by Brugmann University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MODS2 score (time frame: Weaning from cardiopulmonary bypass in the operating room). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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