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.
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.
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.
- Conditions
- Pediatric Cardiac Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Dobutamine | Weaning from cardiopulmonary bypass using dobutamine as inotrope. Receives: Drug: dobu | |
| Milrinone-epinephrine | Weaning 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.
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.
- First posted8 May 2020
- Study start11 May 2020
- Primary completion5 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Fabiola Children's University Hospital
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Choice of Perioperative Inotropes Has Influence on the Morbidity and Mortality of Infants Operated for Complex Heart Defects?
- ClinicalTrials.gov ID
- NCT04380181
- Acronym / sponsor ID
- CHUBpedCSino / CHUB-ped_CS_inotropes
- Conditions
- Pediatric Cardiac Surgery
- Keywords
- pediatric cardiopulmonary bypass, milrinone, dobutamine, epinephrine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Collaborators
- Queen Fabiola Children's University Hospital
- Study start
- 11 May 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dobutamine | – | Drug: dobuWeaning from cardiopulmonary bypass using dobutamine as inotrope. |
| Milrinone-epinephrine | – | –Weaning from cardiopulmonary bypass using milrinone and epinephrine as inotropes. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 1 year undergoing complex cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (7 listed)
- Patient under 1 year old. Cardiac surgery with CPB between 2008-2018. RACHS-1 risk categories >3.
- Transposition of the great arteries
- Atrio-ventricular canal defect
- Aortic coarctation or interruption
- Truncus arteriosus
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dobuAlso: milrinone-epinephrineUse of dobutamine versus milrinone and epinephrine for separation from cardiopulmonary bypass | Drug | Dobutamine |
Primary outcome
MODS2 score
Time frame: Weaning from cardiopulmonary bypass in the operating room
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Pediatric Cardiac Surgery
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Active, not recruiting
Handheld US Device to Verify Vascular Cannulation
Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.