Clinical Application of Cytokine Adsorption Technique in AIDS Patients With Severe Pneumonia and/or Septic Shock
NCT ID: NCT06145828
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2023-10-23
2027-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Guangzhou 8th People's Hospital
OTHER
Responsible Party
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Linghua LI
Chief physician
Principal Investigators
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Linghua Li, PhD
Role: STUDY_CHAIR
Guangzhou Eighth People's Hospital
Locations
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Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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202322259
Identifier Type: -
Identifier Source: org_study_id