HFRSNCT06020326
A Retrospective Cohort Study of HFRS
An observational study of HFRS, run by Tongji Hospital at 8 sites in China.
Trial summary
The goal of this retrospective cohort study is to learn about the clinial characteristics of HFRS patients, explore the risk factors of the occurrence and death of HFRS, and build a risk prediction model for HFRS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFRS
- How many people
- 500 participants
- Where
- 8 sitesChina
- Study dates
- 5 May 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with HFRS diagnosed
Who may be able to join
- The patients must meet all of the following criteria:
- Inpatient with clinical diagnosis of Haemorrhagic Fever with Renal Syndrome
Who cannot join
- Exclude patients who meet any of the following criteria:
- Patients with previous chronic kidney disease
- Pregnant or perinatal patients
- Patients unsuitable for inclusion by investigators' evaluation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
No.1 Peoples Hospital of Guangshui
Guangshui, Hubei
Qian Liu, 13872857607, liuqian060685@163.com
- Recruiting
Huanggang Central Hospital
Huanggang, Hubei
Xiang Guo Zhu, 18602786696, 526896352@qq.com
- Recruiting
People's Hospital of Luotian County
Huanggang, Hubei
Wei Wang, 13409767486, 196436547@qq.com
- Recruiting
People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
Macheng, Hubei
Yi Zhou, 19971181214, 2513478349@qq.com
- Recruiting
Qianjiang Central Hospital
Qianjiang, Hubei
Jun Wang, 13451145526, qjn6249223@163.com
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
Qin Ning, +8613971521450, qning@vip.sina.com
- Recruiting
Xianning Central Hospital
Xianning, Hubei
Jun Zhu, 13117160652, 1356266581@qq.com
- Recruiting
The Third Peoples Hospital of Yichang
Yichang, Hubei
Quan Ming, 13872658268, 737695825@qq.com
About this study
Official title: A Retrospective Cohort Study of Hemorrhagic Fever With Renal Syndrome
The goal of this retrospective cohort study is to learn about the clinial characteristics of HFRS patients, explore the risk factors of the occurrence and death of HFRS, and build a risk prediction model for HFRS.
Read the detailed description
HFRS remains an important public health issue in China, which not only poses a threat to people's physical health and safety, but also has a serious impact on social and economic development. At present, there is no unified standard for clinical prediction of the occurrence and death of HFRS. In order to better prevent and treat HFRS, this multicenter retrospective clinical study is designed to include HFRS inpatients, and collect their demographics, epidemiological history, hospitalization information, clinical manifestation, laboratory results, imaging results, treatment plan and outcome.
- Conditions
- HFRS
- Medical subject headings
- Hemorrhagic Fever with Renal Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term mortality
28-day and 90-day mortality after diagnosed as HFRS
Measured: 90 days post diagnosed HFRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start5 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFRSStudies of the same condition, open and under way.
- More trials run by Tongji 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, Professor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020326
- Sponsor's protocol ID
- REHEAL
- Status last verified
- Jul 2023
- First submitted
- 17 Aug 2023
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of Hemorrhagic Fever With Renal Syndrome
- ClinicalTrials.gov ID
- NCT06020326
- Acronym / sponsor ID
- REHEAL
- Conditions
- HFRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Aug 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.
The goal of this retrospective cohort study is to learn about the clinial characteristics of HFRS patients, explore the risk factors of the occurrence and death of HFRS, and build a risk prediction model for HFRS.
Detailed description
HFRS remains an important public health issue in China, which not only poses a threat to people's physical health and safety, but also has a serious impact on social and economic development. At present, there is no unified standard for clinical prediction of the occurrence and death of HFRS. In order to better prevent and treat HFRS, this multicenter retrospective clinical study is designed to include HFRS inpatients, and collect their demographics, epidemiological history, hospitalization information, clinical manifestation, laboratory results, imaging results, treatment plan and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with HFRS diagnosed
Key inclusion criteria (2 listed)
- Inpatient with clinical diagnosis of Haemorrhagic Fever with Renal Syndrome
Key exclusion criteria (4 listed)
- Patients with previous chronic kidney disease
- Pregnant or perinatal patients
- Patients unsuitable for inclusion by investigators' evaluation
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
short-term mortality
Time frame: 90 days post diagnosed HFRS
28-day and 90-day mortality after diagnosed as HFRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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.
Qin Ning, Professor principal investigator
Tongji Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFRS, run by Tongji Hospital at 8 sites 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 2 inclusion and 4 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term mortality (time frame: 90 days post diagnosed HFRS). 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 31 Aug 2023.