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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145828
• Other study ID #: 202322259
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: October 23, 2027

Study information

• Verified date: November 2023
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, PhD
• Phone: +862083710825
• Email: llheliza[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 23, 2027
• Est. primary completion date: October 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou Eighth People's Hospital, Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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, — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Compare the mortality rates of the cytokine adsorption combined with standard treatment group and the standard treatment group.	4 weeks
Secondary	Improvement in critical care scoring	Improvements in the intensive care scoring systems SOFA score and APACHE II score from baseline and after intervention.	Baseline and during treatment at weeks 1, 2, 3, 4.