Clinical trial NCT06145828: Clinical Application of Cytokine Adsorption Technique in AIDS Patients With Severe Pneumonia and/or Septic Shock
Official title: Clinical Application of Cytokine Adsorption Technology in AIDS Patients With Severe Pneumonia and/or Septic Shock: An Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AIDS Pneumonia
Septic Shock
Keywords: AIDS
Severe Pneumonia
Septic Shock
Cytokine Adsorption Technique
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.

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.

Eligibility criteria: Inclusion Criteria:

1. Confirmed HIV infection;
2. Progression to AIDS stage: CD4+ count \<200 cells/ul and/or occurrence of AIDS opportunistic infections;
3. Age between 18 and 65 years;
4. Meeting the diagnosis of severe pneumonia or septic shock:

   1. 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;
   2. 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:

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

Primary outcomes:
measure: Mortality rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Improvement in critical care scoring
timeFrame: Baseline and during treatment at weeks 1, 2, 3, 4.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital, Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Guangzhou Eighth People's Hospital
name: Linghua Li, PhD
role: STUDY_CHAIR
References:
citation: Pei F, Yao RQ, Ren C, Bahrami S, Billiar TR, Chaudry IH, Chen DC, Chen XL, Cui N, Fang XM, Kang Y, Li WQ, Li WX, Liang HP, Lin HY, Liu KX, Lu B, Lu ZQ, Maegele M, Peng TQ, Shang Y, Su L, Sun BW, Wang CS, Wang J, Wang JH, Wang P, Xie JF, Xie LX, Zhang LN, Zingarelli B, Guan XD, Wu JF, Yao YM; Shock and Sepsis Society of Chinese Research Hospital Association; China Critical Care Immunotherapy Research Group; International Federation of the Shock Societies (IFSS). Expert consensus on the monitoring and treatment of sepsis-induced immunosuppression. Mil Med Res. 2022 Dec 26;9(1):74. doi: 10.1186/s40779-022-00430-y.
citation: Wendel Garcia PD, Hilty MP, Held U, Kleinert EM, Maggiorini M. Cytokine adsorption in severe, refractory septic shock. Intensive Care Med. 2021 Nov;47(11):1334-1336. doi: 10.1007/s00134-021-06512-0. Epub 2021 Sep 1. No abstract available.