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Clinical efficacy of ulinastatin in the treatment of unliquefied Pyogenic liver abscess complicated with septic shock

Clinical efficacy of ulinastatin in the treatment of unliquefied Pyogenic liver abscess complicated with septic shock

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066693
Enrollment
Unknown
Registered
2022-12-14
Start date
2018-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unliquefied Pyogenic liver abscess complicated with septic shock

Interventions

Experimental group:ulinastatin treatment
Control group:Use the same dose of saline

Sponsors

Huai’an First People’s Hospital of Nanjing Medical University(Huai 'an First People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
33 Years to 77 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for unliquefied bacterial liver abscess: (1) symptoms of digestive system infection such as chills, high fever and hepatic pain; (2) Unliquefied bacterial liver abscess was confirmed by B-ultrasound, CT, MRI and other imaging examinations; (3) WBC, CRP, PCT, blood culture and other experimental evidence proved to be infectious lesions; (4) In the absence of clear etiological evidence, the patient's clinical symptoms were controlled and the lesion shrank and disappeared after relevant anti-infective treatment. 2. The inclusion criteria for septic shock are based on the third edition of the Definition of Septic Shock published by the Society for Critical Care Medicine (SCCM)/European Society for Critical Care Medicine (ESICM) : Patients with severe infection had persistent hypotension within 48 hours after the diagnosis of sepsis despite adequate fluid resuscitation and needed to maintain mean arterial pressure above 65 mmHg and blood lactic acid above 2 mmol/L with pressors, with evidence of acute organ dysfunction: The total score of Sequential Organ failure score (SOFA) from 48 hours before infection to 24 hours after infection was =2 points.

Exclusion criteria

Exclusion criteria: (1) LA caused by amoeba, tuberculosis, fungi and other microorganisms; (2) PLA that has been liquefied or needs puncture or operation; (3) 80 years old; (4) Pregnancy or lactation; (5) Grade IV congestive heart failure, non-infectious cardiogenic shock, or uncontrolled acute hemorrhagic shock as defined by the New York Heart Association; (6) Existing severe organic liver disease, such as clinically significant portal hypertension, Child-Pugh stage C cirrhosis or acute liver failure; (7) Previous history of solid organ or bone marrow transplantation; (8) Prior severe pulmonary fibrosis or non-invasive ventilation before onset; (9) myocardial infarction within 3 months before onset; (10) cardiopulmonary resuscitation within 72 hours before onset of illness; (11) invasive fungal infection or active tuberculosis; (12) full-layer thermal or chemical burns of 30% or more of the body surface; (13) There is clear evidence of immunosuppression due to drugs or diseases or any disease that has developed enough to suppress resistance to infection, such as AIDS; (14) Hematologic or lymphatic tumors are not in remission; (15) Allergic history of ulinastatin; (16) previous participants in clinical trials; (17) Patients who cannot obtain informed consent or consent; (18) Expected survival < 2 months or chronic vegetative state; (19) Patients who are not active in comprehensive and active treatment.

Design outcomes

Primary

MeasureTime frame
White Blood Cell;Lactic acid;Procalcitonin;C-reactive protein;Tumour necrosis factor-a;Interleukin-6;Total bilirubin;Alanine transaminase;aspartate transaminase;

Secondary

MeasureTime frame
Length of ICU stay;Duration of fever;Vasoactive drug maintenance time;

Countries

China

Contacts

Public Contactzhoubing

Huai 'an First People's Hospital

hayyzb@126.com13813453501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026