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NCT Number: NCT06145828

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cytokine Adsorption

Device

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.

Primary outcomes

  1. 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

  1. Improvement in critical care scoring

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linghua Li, PhD

CONTACT

[email protected]

+862083710825

Yaozu He, MD

CONTACT

[email protected]

+862083710825

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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