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RecruitingNCT06145828Updated Nov 24, 2023

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

An observational study in AIDS Pneumonia and Septic Shock, sponsored by Guangzhou 8th People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Guangzhou 8th People's Hospital · Observational

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • AIDS Pneumonia
  • Septic Shock

Keywords

  • AIDS
  • Severe Pneumonia
  • Septic Shock
  • Cytokine Adsorption Technique
03

In context

Shock, Septic

890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 309 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Guangzhou 8th People's Hospital is the lead sponsor of 17 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceCytokine 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.

06

What researchers measure

Primary outcomes

  1. Mortality rate

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

    Time frame: 4 weeks

Secondary outcomes

  1. Improvement in critical care scoring

    Improvements in the intensive care scoring systems SOFA score and APACHE II score from baseline and after intervention.

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

07

Study locations

1 of 1 sites recruiting
  • Guangzhou Eighth People's Hospital, Guangzhou Medical University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36567402 ↗
  • 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. PubMed 34471938 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.

Of 137 non-industry observational studies under Shock, Septic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 36 months is above that.

Counting every sponsor, half of 147 studies reached it within 28 months; a quarter within 13 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2023
First posted
Nov 24, 2023
StartActual
Oct 23, 2023
Primary completionEst.
Oct 23, 2026
CompletionEst.
Oct 23, 2027
Last update
Nov 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06145828
Lead sponsor
Guangzhou 8th People's Hospital
Responsible party
Linghua LI (Chief physician, Guangzhou 8th People's Hospital) — Principal investigator
First posted
Nov 24, 2023
Start date
Oct 23, 2023
Primary completion
Oct 23, 2026 (estimated)
Completion
Oct 23, 2027 (estimated)
Last update
Nov 24, 2023

Study contacts

Linghua Li, PhD
Contact
llheliza@126.com
+862083710825
Yaozu He, MD
Contact
hyzdyl99@163.com
+862083710825
Linghua Li, PhD
study chair · Guangzhou Eighth People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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