InfectionsNCT05099120
Establishment of Risk Indicators and Early Warning System in Infection Patients
An observational study of Infections, run by Xijing Hospital.
Trial summary
Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections
- How many people
- 16,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We integrated pooled individual patient data of infected patients treated at a single center in China from 1 January 2010 until 31 July 2021.
Who may be able to join
- Patients diagnosed with infection
Who cannot join
- Case information is incomplete
- Do not accept follow-up
About this study
Official title: Establishment of Risk Indicators and Early Warning System for Deterioration of Infected Patients in Real-world Data.
Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Patients with severe infections have rapid disease development, which can cause disorders of cellular circulation and metabolism and impairment of multi-organ function in the early stage, mostly accompanied by clinical complications, and despite the progress of medical technology and the popularization of antibiotic application, the mortality and disability rate is high, which is a hot spot of clinical research today. Patients with severe infections are exposed to a wide range of medical risk factors, including patient factors (advanced age, frailty, malnutrition, long hospital stay, prolonged bed rest), disease factors (immune deficiency, malignancy, diabetes, renal failure, liver failure), drug factors (long-term use of steroid hormones, chemotherapeutic drugs, NSAIDs, etc.), interventional factors (central venous catheter, recent invasive surgery, hemodialysis, endotracheal intubation or mechanical ventilation, etc.), which bring great challenges to clinical treatment. Therefore, early identification of risk indicators for deterioration of infected patients provides a strategic basis for the medical team to take early warning measures to prevent deterioration and poor prognosis, and to reduce the risk of deterioration of patients, which is also the key to reduce the risk of death of infected patients.
- Conditions
- Infections
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Among patients with infections admitted to the hospital
primary outcome measure were defined as the death.
Measured: 30 days of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jan 2010
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingwen Wang, Study director, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099120
- Sponsor's protocol ID
- Jingwen Wang
- Status last verified
- Aug 2021
- First submitted
- 11 Oct 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Risk Indicators and Early Warning System for Deterioration of Infected Patients in Real-world Data.
- ClinicalTrials.gov ID
- NCT05099120
- Acronym / sponsor ID
- Jingwen Wang
- Conditions
- Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Oct 2021 (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.
Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Patients with severe infections have rapid disease development, which can cause disorders of cellular circulation and metabolism and impairment of multi-organ function in the early stage, mostly accompanied by clinical complications, and despite the progress of medical technology and the popularization of antibiotic application, the mortality and disability rate is high, which is a hot spot of clinical research today. Patients with severe infections are exposed to a wide range of medical risk factors, including patient factors (advanced age, frailty, malnutrition, long hospital stay, prolonged bed rest), disease factors (immune deficiency, malignancy, diabetes, renal failure, liver failure), drug factors (long-term use of steroid hormones, chemotherapeutic drugs, NSAIDs, etc.), interventional factors (central venous catheter, recent invasive surgery, hemodialysis, endotracheal intubation or mechanical ventilation, etc.), which bring great challenges to clinical treatment. Therefore, early identification of risk indicators for deterioration of infected patients provides a strategic basis for the medical team to take early warning measures to prevent deterioration and poor prognosis, and to reduce the risk of deterioration of patients, which is also the key to reduce the risk of death of infected patients.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We integrated pooled individual patient data of infected patients treated at a single center in China from 1 January 2010 until 31 July 2021.
Key inclusion criteria (1 listed)
- Patients diagnosed with infection
Key exclusion criteria (2 listed)
- Case information is incomplete
- Do not accept follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Among patients with infections admitted to the hospital
Time frame: 30 days of hospitalization
primary outcome measure were defined as the death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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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. This study is not recruiting at the moment.
Jingwen Wang study director
The First Affiliated Hospital of Air Force Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by Xijing Hospital.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Among patients with infections admitted to the hospital (time frame: 30 days of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2022.