Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Model scores of the 29,894 trials active now.
Model score 29% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (313 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-08-24, after 2018-03-07 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 2022-08-24. 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: hourssepsisto determineacuteintravenous
Phrases that lowered it: mmhgblood pressureedemaclinicalknown or -
Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 41.8% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports marked serious: 95.5% (raises risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
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Sponsor's past trials: 762 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 218 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
-
Drug's FAERS reports before start: 3515 (raises risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 762 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 218 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3515 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 662 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 41.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- norepinephrine
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
- Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock NCT03366220 · started 2018 · scored riskier than 97% of active trials terminated
- Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients NCT05076435 · started 2021 · scored riskier than 82% of active trials completed
- Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis NCT04102371 · started 2020 · scored riskier than 58% of active trials completed
- Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension NCT01271114 · started 2012 · scored riskier than 70% of active trials terminated
- Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma NCT01411852 · started 2012 · scored riskier than 84% 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.