Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 7% 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 2017-04-25, after 2014-10-15 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 2017-04-25. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartinjuryhoursacute24
Phrases that lowered it: the aimmoderateaim ofeffect ofmild -
Sponsor's past termination rate: 2.1% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports with a death: 41.2% (raises risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports marked serious: 96.6% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Responsible party: principal investigator (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Collaborators: 1 (raises risk) · Design
-
Blinding: double (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
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Maximum age: 1 (raises risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.08 (typical: 18)
- Maximum age
- 1 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 48 (typical: 32)
- Sponsor's past termination rate
- 2.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 23 (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
- 735 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 55 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 41.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- levosimendan, milrinone
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
- Fenoldopam in Pediatric Cardiac Surgery NCT00982527 · started 2009 · scored riskier than 52% of active trials completed
- Use of Dexmedetomidine in Children Undergoing Cardiac Surgery NCT02375243 · started 2014 · scored riskier than 30% of active trials completed
- L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects NCT02891837 · started 2016 · scored riskier than 23% of active trials completed
- A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI) NCT01830920 · started 2013 · scored riskier than 82% 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
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.