Sepsis-Associated EncephalopathyNCT07090278
Ulinastatin Treatment Reduces the Incidence of Sepsis-associated Encephalopathy
An observational study of Sepsis-Associated Encephalopathy, run by Shusheng Li at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis-Associated Encephalopathy
- What is being tested?
- ulinastatin
- How many people
- 2,734 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis in the ICU
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
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.
Read the detailed description
This study consisted of two parts: a retrospective, multicenter observational derivation cohort and a prospective, single-center observational validation cohort. Both parts of the study included adult patients admitted to the intensive care unit of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The first part of the study, being retrospective in nature, was exempted from obtaining informed consent. However, all participants in the second part of the study signed a written informed consent form. The first part of the study retrospectively collected adult patients with sepsis according to the inclusion and exclusion criteria, explored the factors related to sepsis-related encephalopathy, and analyzed the correlation between the use of ulinastatin treatment and the occurrence of SAE. The second part of the study was a prospective study. After signing the informed consent form, eligible patients were included. After collecting blood routine or arterial blood gas analysis, the remaining blood was centrifuged and the plasma was frozen at -80°C for subsequent detection of nitric oxide.
The primary exposure variable was the administration of ulinastatin in patients with sepsis. Demographic data, including age and gender, were collected at ICU admission. Additional exposure variables included blood biochemical markers and infection-related indicators. Clinical comorbidities were recorded based on established diagnoses documented in the medical record, including hypertension, coronary artery disease, atrial fibrillation, diabetes, respiratory diseases (chronic obstructive pulmonary disease, asthma, chronic bronchitis, and bronchiectasis), renal dysfunction, history of tumor, history of stroke, and liver cirrhosis.
The primary outcome was the occurrence of SAE within 3 days of enrollment. Secondary outcomes in the prospective cohort included the fasting blood glucose/ high density lipoprotein cholesterol (FBG/HDL-C), in-hospital mortality, 28-day survival rate, and 28-day survival time.
- Conditions
- Sepsis-Associated Encephalopathy
- Being tested
- ulinastatin
- Keywords
- sepsis, sepsis-associated encephalopathy, ulinastatin
- Medical subject headings
- Sepsis-Associated Encephalopathy, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Ulinastatin for the treatment of sepsis patients during ICU stay
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin Group | Patients diagnosed with sepsis who received ulinastatin as part of routine clinical care. The use of ulinastatin was not assigned by study protocol but determined by treating physicians. Clinical outcomes, including the incidence of SAE, were assessed. Receives: Drug: ulinastatin | |
| Non-Ulinastatin Group | Patients diagnosed with sepsis who did not receive ulinastatin treatment during hospitalization. Clinical outcomes, including the incidence of SAE, were recorded. No study-specific interventions were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of sepsis-associated encephalopathy (SAE)
Glasgow Coma Scale (GCS) score of less than 15 or the presence of delirium symptoms confirmed by the Confusion Assessment Method for the ICU (CAM-ICU)
Measured: 3 days
Secondary outcomes (3)
In-hospital mortality
In-hospital mortality will be assessed by reviewing medical records from the time of admission to discharge. Deaths occurring during the hospitalization period will be recorded.
Measured: From hospital admission until discharge or in-hospital death, whichever occurred first, assessed up to 90 days.
Survival time
Patients will be followed up for 28 days after enrollment, and the survival time and rate within 28 days will be recorded
Measured: 28 days
FBG/HDL-C ratio (fasting blood glucose to high-density lipoprotein cholesterol ratio)
The FBG/HDL-C ratio will be calculated as a single continuous variable (fasting blood glucose divided by HDL-C). This is a single outcome measure. Record the patient's FBG/HDL-C on the 3rd day.
Measured: 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jan 2019
- Primary completion31 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis-Associated EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shusheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shusheng Li, Tongji Hospital
- Investigators
- Shusheng Li, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090278
- Sponsor's protocol ID
- SAE-UTI
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu T, Zhang Q, Ruan H, Ran X, Li S. Ulinastatin Treatment Associated with Lower Sepsis-Associated Encephalopathy Risk in Sepsis Patients: A Multicenter Observational Study. Shock. 2026 Jul 1;66(1):99-109. doi: 10.1097/SHK.0000000000002751. Epub 2025 Dec 1.
PubMed 42376927
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulinastatin Treatment Reduces the Incidence of Sepsis-associated Encephalopathy
- ClinicalTrials.gov ID
- NCT07090278
- Acronym / sponsor ID
- SAE-UTI
- Conditions
- Sepsis-Associated Encephalopathy
- Keywords
- sepsis, sepsis-associated encephalopathy, ulinastatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,734 participants (actual)
- Lead sponsor
- Shusheng LiUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consisted of two parts: a retrospective, multicenter observational derivation cohort and a prospective, single-center observational validation cohort. Both parts of the study included adult patients admitted to the intensive care unit of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The first part of the study, being retrospective in nature, was exempted from obtaining informed consent. However, all participants in the second part of the study signed a written informed consent form. The first part of the study retrospectively collected adult patients with sepsis according to the inclusion and exclusion criteria, explored the factors related to sepsis-related encephalopathy, and analyzed the correlation between the use of ulinastatin treatment and the occurrence of SAE. The second part of the study was a prospective study. After signing the informed consent form, eligible patients were included. After collecting blood routine or arterial blood gas analysis, the remaining blood was centrifuged and the plasma was frozen at -80°C for subsequent detection of nitric oxide.
The primary exposure variable was the administration of ulinastatin in patients with sepsis. Demographic data, including age and gender, were collected at ICU admission. Additional exposure variables included blood biochemical markers and infection-related indicators. Clinical comorbidities were recorded based on established diagnoses documented in the medical record, including hypertension, coronary artery disease, atrial fibrillation, diabetes, respiratory diseases (chronic obstructive pulmonary disease, asthma, chronic bronchitis, and bronchiectasis), renal dysfunction, history of tumor, history of stroke, and liver cirrhosis.
The primary outcome was the occurrence of SAE within 3 days of enrollment. Secondary outcomes in the prospective cohort included the fasting blood glucose/ high density lipoprotein cholesterol (FBG/HDL-C), in-hospital mortality, 28-day survival rate, and 28-day survival time.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin Group | – | Drug: ulinastatinPatients diagnosed with sepsis who received ulinastatin as part of routine clinical care. The use of ulinastatin was not assigned by study protocol but determined by treating physicians. Clinical outcomes, including the incidence of SAE, were assessed. |
| Non-Ulinastatin Group | – | –Patients diagnosed with sepsis who did not receive ulinastatin treatment during hospitalization. Clinical outcomes, including the incidence of SAE, were recorded. No study-specific interventions were applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis in the ICU
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulinastatinUlinastatin for the treatment of sepsis patients during ICU stay | Drug | Ulinastatin Group |
Primary outcome
The incidence of sepsis-associated encephalopathy (SAE)
Time frame: 3 days
Glasgow Coma Scale (GCS) score of less than 15 or the presence of delirium symptoms confirmed by the Confusion Assessment Method for the ICU (CAM-ICU)
3 secondary outcomes
In-hospital mortality
Time frame: From hospital admission until discharge or in-hospital death, whichever occurred first, assessed up to 90 days.
Survival time
Time frame: 28 days
FBG/HDL-C ratio (fasting blood glucose to high-density lipoprotein cholesterol ratio)
Time frame: 3rd day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 42376927Xu T, Zhang Q, Ruan H, Ran X, Li S. Ulinastatin Treatment Associated with Lower Sepsis-Associated Encephalopathy Risk in Sepsis Patients: A Multicenter Observational Study. Shock. 2026 Jul 1;66(1):99-109. doi: 10.1097/SHK.0000000000002751. Epub 2025 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shusheng Li, PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis-Associated Encephalopathy, run by Shusheng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of sepsis-associated encephalopathy (SAE) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07090278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.