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Clinical Trials/NCT06145828
NCT06145828RecruitingNot Applicable

Clinical Application of Cytokine Adsorption Technology in AIDS Patients With Severe Pneumonia and/or Septic Shock: An Observational Study.

Guangzhou 8th People's Hospital1 site in 1 country60 target enrollmentStarted: October 23, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Mortality rate

Study Overview

Brief Summary

Observing the Real-World Application Effectiveness of Cytokine Immune Adsorption Technology in AIDS Patients with Severe Pneumonia or septic shock.

Detailed Description

This is a prospective, single-center, non-randomized, clinical observational cohort study primarily focused on observing the clinical effects of cytokine adsorption technology in patients with AIDS complicated by severe pneumonia and/or septic shock. Based on the real-world application of cytokine adsorption technology in AIDS patients with severe pneumonia or septic shock, the study divides patients into two groups: one receiving cytokine adsorption combined with standard treatment, and another receiving standard treatment only. The study aims to observe the impact of these two different treatment strategies on clinical outcomes.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed HIV infection;
  • Progression to AIDS stage: CD4+ count <200 cells/ul and/or occurrence of AIDS opportunistic infections;
  • Age between 18 and 65 years;
  • Meeting the diagnosis of severe pneumonia or septic shock:
  • The criteria for severe pneumonia diagnosis refer to the 2021 ATS (American Thoracic Society) and IDSA (Infectious Diseases Society of America) guidelines for the treatment of community-acquired pneumonia;
  • The criteria for septic shock refer to the Chinese Society of Critical Care Medicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018).

Exclusion Criteria

  • Coexisting central nervous system lesions, severe liver disease, or cirrhosis;
  • Concurrent AIDS-related or unrelated tumors;
  • Women who are pregnant or breastfeeding;
  • Severe underlying diseases of the heart, lungs, liver, kidneys, etc.;
  • Alcohol abuse or drug use;
  • The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.

Outcomes

Primary Outcomes

Mortality rate

Time Frame: 4 weeks

Compare the mortality rates of the cytokine adsorption combined with standard treatment group and the standard treatment group.

Secondary Outcomes

  • Improvement in critical care scoring(Baseline and during treatment at weeks 1, 2, 3, 4.)

Investigators

Sponsor
Guangzhou 8th People's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Linghua LI

Chief physician

Guangzhou 8th People's Hospital

Study Sites (1)

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