Clinical Application of Cytokine Adsorption Technique in AIDS Patients With Severe Pneumonia and/or Septic Shock

Sponsor

Guangzhou 8th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145828

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AIDS Pneumonia Septic Shock	Device: Cytokine Adsorption

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

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 23, 2023

Anticipated Primary Completion Date :

Oct 23, 2026

Anticipated Study Completion Date :

Oct 23, 2027

Arms and Interventions

Arm	Intervention/Treatment
Cytokine Adsorption Combined with Standard Treatment Group This group receives cytokine adsorption combined with standard treatment, specifically via hemoperfusion using the standard 211 protocol: two hemoperfusions within the first 24 hours, followed by one hemoperfusion daily. Each hemoperfusions session does not exceed 6 hours, lasting a total of 3 days. All patients also undergo blood perfusion treatment with the addition of a plasma separator.	Device: Cytokine Adsorption During treatment with cytokine adsorption cartridge, the patient's blood is passed through these cartridges, which contain substances that can adsorb specific cytokines. Excess cytokines are captured and removed by these substances, and then the cleansed blood is returned to the patient's body.
Standard Treatment Group This group receives only standard treatment . Standard treatment includes symptomatic supportive therapy, etiological therapy, fluid resuscitation, application of vasopressors, and non-invasive or invasive ventilation therapy.

Arm

Intervention/Treatment

Cytokine Adsorption Combined with Standard Treatment Group

This group receives cytokine adsorption combined with standard treatment, specifically via hemoperfusion using the standard 211 protocol: two hemoperfusions within the first 24 hours, followed by one hemoperfusion daily. Each hemoperfusions session does not exceed 6 hours, lasting a total of 3 days. All patients also undergo blood perfusion treatment with the addition of a plasma separator.

Device: Cytokine Adsorption

During treatment with cytokine adsorption cartridge, the patient's blood is passed through these cartridges, which contain substances that can adsorb specific cytokines. Excess cytokines are captured and removed by these substances, and then the cleansed blood is returned to the patient's body.

Standard Treatment Group

This group receives only standard treatment . Standard treatment includes symptomatic supportive therapy, etiological therapy, fluid resuscitation, application of vasopressors, and non-invasive or invasive ventilation therapy.

Outcome Measures

Primary Outcome Measures

Mortality rate [4 weeks]
Compare the mortality rates of the cytokine adsorption combined with standard treatment group and the standard treatment group.

Secondary Outcome Measures

Improvement in critical care scoring [Baseline and during treatment at weeks 1, 2, 3, 4.]
Improvements in the intensive care scoring systems SOFA score and APACHE II score from baseline and after intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.