Ulinastatin Treatment Reduces the Incidence of Sepsis-associated Encephalopathy

NCT07090278 | Completed

• 1 other identifier: SAE-UTI
• Study Type: observational
• Target: 2,734
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis-Associated Encephalopathy

Keywords

sepsis; sepsis-associated encephalopathy; ulinastatin

Outcome Measures

Primary Outcomes (1)

• 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)

  3 days

Secondary Outcomes (3)

• In-hospital mortality

  From hospital admission until discharge or in-hospital death, whichever occurred first, assessed up to 90 days.

• Survival time

  28 days

• FBG/HDL-C ratio (fasting blood glucose to high-density lipoprotein cholesterol ratio)

  3rd day

Study Arms (2)

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.

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.

Interventions

ulinastatin DRUG

Ulinastatin for the treatment of sepsis patients during ICU stay

Ulinastatin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sepsis in the ICU

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shusheng Li: lead

Study Sites (1)

Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In the prospective cohort, the remaining blood after blood routine or arterial blood gas analysis was quickly centrifuged to separate plasma. Plasma samples were immediately stored at -80°C in a dedicated biobank for subsequent batch analysis.

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy; Sepsis

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shusheng Li, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 29, 2025
• Study Start: January 1, 2019
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)