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

NCT06145828 | Recruiting DMC

• 1 other identifier: 202322259
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AIDS Pneumonia; Septic Shock

Keywords

AIDS; Severe Pneumonia; Septic Shock; Cytokine Adsorption Technique

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  Compare the mortality rates of the cytokine adsorption combined with standard treatment group and the standard treatment group.

  4 weeks

Secondary Outcomes (1)

• Improvement in critical care scoring

  Baseline and during treatment at weeks 1, 2, 3, 4.

Study Arms (2)

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

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.

Interventions

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.

Cytokine Adsorption Combined with Standard Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou 8th People's Hospital: lead

Study Sites (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related 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, 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.

  PMID: 36567402 RESULT

• 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.

  PMID: 34471938 RESULT

MeSH Terms

Conditions

Shock, Septic; Acquired Immunodeficiency Syndrome; Pneumonia

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Linghua Li, PhD

  Guangzhou Eighth People's Hospital

  STUDY CHAIR

Central Study Contacts

Linghua Li, PhD

CONTACT

+862083710825; llheliza@126.com

Yaozu He, MD

CONTACT

+862083710825; hyzdyl99@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 24, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2027
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

CN (1)