Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open Heart Surgery in Pediatrics
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-09-25, after 2022-04-15 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-09-25. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: injuryheartmyocardialsurgerydl
Phrases that lowered it: effect ofopenkgexposedrelease -
Sponsor's past termination rate: 0.6% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 31.8% (raises risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Primary purpose: supportive care (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 606 (raises risk) · Sponsor's track record
-
Responsible party: principal investigator (lowers risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Minimum age: 0.5 (lowers risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor's past trials: 660 (raises risk) · Sponsor's track record
-
Drug's FAERS reports before start: 171248 (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Maximum age: 2 (raises risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- supportive care (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.5 (typical: 18)
- Maximum age
- 2 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 660 (typical: 32)
- Sponsor's past termination rate
- 0.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 606 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 171248 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16346 (typical: 412.5)
- Drug's FAERS reports marked serious
- 82.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 31.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dexmedetomidine, fentanyl, isoflurane, ketamine, midazolam
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study NCT05300802 · started 2021 · scored riskier than 36% of active trials completed
- Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass NCT00585013 · started 2008 · scored riskier than 99% of active trials completed
- Pediatric Myocardial Protection With Potassium Cardioplegia NCT03229980 · started 2017 · scored riskier than 18% of active trials completed
- Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation NCT02519335 · started 2014 · scored riskier than 85% of active trials terminated
- Neuroprotection During Open Heart Surgery NCT04486690 · started 2016 · scored riskier than 51% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.