Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis
Model scores of the 29,894 trials active now.
Model score 21% 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 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 2020-09-30, after 2019-09-01 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 2020-09-30. 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: treatedacuteorganflowfailure
Phrases that lowered it: respiratoryperiodpressurenasalblood -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Responsible party: principal investigator (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 66.0% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 7.3% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports before start: 312005 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 37238 (lowers risk) · Drug's FDA history
-
Maximum age: not given (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers 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
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 5 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 312005 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 37238 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- ascorbic acid, hydrocortisone, vitamin b
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
- Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock NCT04111822 · started 2018 · scored riskier than 72% of active trials completed
- Vitamin C, Thiamine, and Steroids in Sepsis NCT03509350 · started 2018 · scored riskier than 86% of active trials completed
- Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock NCT05192213 · started 2021 · scored riskier than 64% of active trials terminated
- Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury NCT02106975 · started 2014 · scored riskier than 92% of active trials completed
- Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis. NCT03422159 · started 2018 · scored riskier than 69% 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.