AIDS PneumoniaNCT06145828
Clinical Application of Cytokine Adsorption Technique in AIDS Patients With Severe Pneumonia and/or Septic Shock
An observational study of AIDS Pneumonia and Septic Shock, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
Observing the Real-World Application Effectiveness of Cytokine Immune Adsorption Technology in AIDS Patients with Severe Pneumonia or septic shock. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS Pneumonia, Septic Shock
- What is being tested?
- Cytokine Adsorption
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to 23 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510060
Linghua Li, PhD, +862083710825, llheliza@126.com
Yaozu He, MD, +862083710825, hyzdyl99@163.com
About this study
Official title: Clinical Application of Cytokine Adsorption Technology in AIDS Patients With Severe Pneumonia and/or Septic Shock: An Observational Study.
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.
- Conditions
- AIDS Pneumonia, Septic Shock
- Being tested
- Cytokine Adsorption
- Keywords
- AIDS, Severe Pneumonia, Septic Shock, Cytokine Adsorption Technique
- Medical subject headings
- Shock, Septic, Acquired Immunodeficiency Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine AdsorptionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Compare the mortality rates of the cytokine adsorption combined with standard treatment group and the standard treatment group.
Measured: 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.
Measured: Baseline and during treatment at weeks 1, 2, 3, 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start23 Oct 2023
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AIDS PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linghua LI, Guangzhou 8th People's Hospital
- Investigators
- Linghua Li, PhD, Study chair, Guangzhou Eighth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145828
- Sponsor's protocol ID
- 202322259
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 36567402Wendel 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Cytokine Adsorption Technology in AIDS Patients With Severe Pneumonia and/or Septic Shock: An Observational Study.
- ClinicalTrials.gov ID
- NCT06145828
- Acronym / sponsor ID
- 202322259
- Conditions
- AIDS Pneumonia, Septic Shock
- Keywords
- AIDS, Severe Pneumonia, Septic Shock, Cytokine Adsorption Technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2027 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytokine Adsorption Combined with Standard Treatment Group | – | Device: Cytokine AdsorptionThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytokine AdsorptionDuring 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. | Device | Cytokine Adsorption Combined with Standard Treatment Group |
Primary outcome
Mortality rate
Time frame: 4 weeks
Compare the mortality rates of the cytokine adsorption combined with standard treatment group and the standard treatment group.
1 secondary outcome
Improvement in critical care scoring
Time frame: Baseline and during treatment at weeks 1, 2, 3, 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Results publication: PubMed 36567402Pei 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.
- Results publication: PubMed 34471938Wendel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linghua Li, PhD study chair
Guangzhou Eighth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS Pneumonia and Septic Shock, run by Guangzhou 8th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linghua Li, PhD (+862083710825, llheliza@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.