CompletedNot Applicable

Ulinastatin Treatment Reduces the Incidence of Sepsis-associated Encephalopathy

China2,734 participantsStarted 2019-01-01

Plain-language summary

This study was conducted to explore the association between ulinastatin treatment and the incidence of sepsis-associated encephalopathy (SAE) in patients with sepsis. The study was divided into two phases: first, a multicenter retrospective observational cohort: to evaluate the correlation between ulinastatin treatment and the risk of SAE; second, a single center prospective observational cohort: to further explore the association between ulinastatin treatment and SAE.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥18 years * ICU stay ≥24 hours * ulfillment of the diagnostic criteria for sepsis according to the Sepsis-3 definition, which included: * (a) suspected or confirmed infection based on clinical evidence and/or positive microbiological findings; * (b) Sequential Organ Failure Assessment (SOFA) score ≥2 points Exclusion Criteria: * cognitive impairment related to sedation * pregnancy * inability to communicate effectively due to visual, auditory, or language disorders * primary central nervous system diseases (e.g., cerebrovascular disease, central nervous system infection, autoimmune encephalitis, or epileptic seizures) * intolerance or allergy to benzodiazepines, or a history of myasthenia gravis, schizophrenia, or severe depressive disorder * metabolic encephalopathy (including hypoglycemia, diabetic ketoacidosis, hepatic encephalopathy, pulmonary encephalopathy, or uremic encephalopathy) * poisoning * skull fracture or intracranial injury

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of sepsis-associated encephalopathy (SAE)

Timeframe: 3 days

Trial details

NCT IDNCT07090278

SponsorShusheng Li

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Sepsis-Associated Encephalopathy trials