Lower Respiratory InfectionNCT05355324
Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults
An observational study of Lower Respiratory Infection and Anemia, run by Beijing Tongren Hospital.
Trial summary
Lower respiratory tract infection(LRTI) is a prevalent disease that threatens the health of older people worldwide. Anemia is also a common disorder in the elderly, and its prevalence increases significantly with age. Most factors that contribute to the development of anemia are improvable. Read more about this study
- Who is it for?
- Ages 80 to 100 years
- Conditions the study is for
- Lower Respiratory Infection, Anemia, Readmission
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 31 Dec 2021
- 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 80 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (age: ≥ 80 years), hospitalized (from 31 March 2016 to 27 December 2019) at the Department of Geriatrics of a hospital in Beijing, China, and were with lower respiratory tract infection(LRTI) (including pneumonia and acute exacerbation of chronic obstructive pulmonary disease) were included. 215 patients (age: >/=80 years) who were hospitalized due to LRTI and discharged after being cured were studied. Of these 215 patients, 149 belonged to the anemia group, and 66 belonged to the non-anemia group. The mean age of the cohort at the time of inclusion was 88.73 (SD 4.765) years, and 77.2% of the patients were men.
Who may be able to join
- Age ≥ 80 years
- lower respiratory tract infection
Who cannot join
- Died at the time of first admission
- Active malignancy
- Tuberculosis
- Anemia caused by gastrointestinal bleeding of unknown origin
- Achalasia of the cardia
- Could not be followed up after discharge
- Data were missing
About this study
Official title: Anemia is a Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults
Lower respiratory tract infection(LRTI) is a prevalent disease that threatens the health of older people worldwide. Anemia is also a common disorder in the elderly, and its prevalence increases significantly with age. Most factors that contribute to the development of anemia are improvable. Therefore, we investigated whether anemia was a risk factor for LRTI-caused readmission and death in the elderly occurring within 1 year of discharge from the hospital.
Read the detailed description
Objectives: To investigate the effect of anemia on readmission and deaths in the older adults following lower respiratory tract infection (LRTI)-caused hospitalization.
Design: A retrospective cohort study. Setting and Participants: Older patients (age: ≥ 80 years) hospitalized at the Department of Geriatrics, from March 2016 to December 2019 to undergo treatment for LRTIs were included.
Methods: The patients were divided into two groups (anemia and non-anemia) based on the level of hemoglobin. They were kept under observation till the occurrence of mortality event or 1 year after discharge. The primary follow-up outcome was LRTI-caused readmission and/or death.
- Conditions
- Lower Respiratory Infection, Anemia, Readmission, Death
- Being tested
- no intervention
- Medical subject headings
- Anemia, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| anemia | patients with anemia Receives: Other: no intervention | |
| non-anemia | patients without anemia Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Readmission and/ or Death Caused by Lower Respiratory Tract Infection(LRTI) within One Year of Discharge
Number of Patients with Readmission Caused by LRTI within One Year of Discharge. Number of Patients with Death Caused by LRTI within One Year of Discharge.
Measured: March 2016 to 27 December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Mar 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355324
- Sponsor's protocol ID
- YuHe_1987
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He Y, Chen Y, Cao K, Zheng H. Effect of Anemia on Readmission and Death in Octogenarian Patients with Lower Respiratory Tract Infections: A Retrospective Cohort Study. Int J Clin Pract. 2022 Oct 27;2022:4566936. doi: 10.1155/2022/4566936. eCollection 2022.
PubMed 36349057
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia is a Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults
- ClinicalTrials.gov ID
- NCT05355324
- Acronym / sponsor ID
- YuHe_1987
- Conditions
- Lower Respiratory Infection, Anemia, Readmission, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 May 2022 (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.
Lower respiratory tract infection(LRTI) is a prevalent disease that threatens the health of older people worldwide. Anemia is also a common disorder in the elderly, and its prevalence increases significantly with age. Most factors that contribute to the development of anemia are improvable. Therefore, we investigated whether anemia was a risk factor for LRTI-caused readmission and death in the elderly occurring within 1 year of discharge from the hospital.
Detailed description
Objectives: To investigate the effect of anemia on readmission and deaths in the older adults following lower respiratory tract infection (LRTI)-caused hospitalization.
Design: A retrospective cohort study. Setting and Participants: Older patients (age: ≥ 80 years) hospitalized at the Department of Geriatrics, from March 2016 to December 2019 to undergo treatment for LRTIs were included.
Methods: The patients were divided into two groups (anemia and non-anemia) based on the level of hemoglobin. They were kept under observation till the occurrence of mortality event or 1 year after discharge. The primary follow-up outcome was LRTI-caused readmission and/or death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anemia | – | Other: no interventionpatients with anemia |
| non-anemia | – | Other: no interventionpatients without anemia |
Who may qualify
- Ages
- 80 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (age: ≥ 80 years), hospitalized (from 31 March 2016 to 27 December 2019) at the Department of Geriatrics of a hospital in Beijing, China, and were with lower respiratory tract infection(LRTI) (including pneumonia and acute exacerbation of chronic obstructive pulmonary disease) were included. 215 patients (age: >/=80 years) who were hospitalized due to LRTI and discharged after being cured were studied. Of these 215 patients, 149 belonged to the anemia group, and 66 belonged to the non-anemia group. The mean age of the cohort at the time of inclusion was 88.73 (SD 4.765) years, and 77.2% of the patients were men.
Key inclusion criteria (2 listed)
- Age ≥ 80 years
- lower respiratory tract infection
Key exclusion criteria (7 listed)
- Died at the time of first admission
- Active malignancy
- Tuberculosis
- Anemia caused by gastrointestinal bleeding of unknown origin
- Achalasia of the cardia
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 |
|---|---|---|
| no interventionno intervention | Other | anemia, non-anemia |
Primary outcome
Number of Patients with Readmission and/ or Death Caused by Lower Respiratory Tract Infection(LRTI) within One Year of Discharge
Time frame: March 2016 to 27 December 2019
Number of Patients with Readmission Caused by LRTI within One Year of Discharge. Number of Patients with Death Caused by LRTI within One Year of Discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 36349057He Y, Chen Y, Cao K, Zheng H. Effect of Anemia on Readmission and Death in Octogenarian Patients with Lower Respiratory Tract Infections: A Retrospective Cohort Study. Int J Clin Pract. 2022 Oct 27;2022:4566936. doi: 10.1155/2022/4566936. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Respiratory Infection and Anemia, run by Beijing Tongren 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 2 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients with Readmission and/ or Death Caused by Lower Respiratory Tract Infection(LRTI) within One Year of Discharge (time frame: March 2016 to 27 December 2019). 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 NCT05355324, which also lists 1 linked publication.
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 2 May 2022.