Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2013-12-31, after 2008-11-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2013-12-31. 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
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: surgerycardiacmeasurableventriculardiagnosis
Phrases that lowered it: extensioncomparisondrugsrandomizedclinical -
Phase: 2 (raises risk) · Design
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Minimum age: 0.08 (lowers risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 24.1% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Keywords listed: 7 (raises risk) · Design
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Maximum age: 3 (raises risk) · Who can join
-
Blinding: double (raises risk) · Design
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Drug's FAERS reports before start: 6655 (raises risk) · Drug's FDA history
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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 0.08 (typical: 18)
- Maximum age
- 3 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6655 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1391 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- dexmedetomidine, fentanyl
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
- Use of Dexmedetomidine in Children Undergoing Cardiac Surgery NCT02375243 · started 2014 · scored riskier than 30% of active trials completed
- Dexmedetomidine Infusion in Hypospadias Surgery NCT00926705 · started 2008 · scored riskier than 10% of active trials completed
- Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP NCT02400047 · started 2015 · scored riskier than 61% of active trials completed
- Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children NCT04535089 · started 2020 · scored riskier than 7% of active trials completed
- Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study NCT02492269 · started 2014 · scored riskier than 60% 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.