In-Hospital Cardiac ArrestNCT04670458
Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit
An observational study of In-Hospital Cardiac Arrest, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- In-Hospital Cardiac Arrest
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in the intensive care unit (ICU, CCU, RICU, EICU, NCU and DICU) of Qilu Hospital of Shandong University from January 1, 2017 to October 31, 2019 were selected.
Who may be able to join
- Occurrence of IHCA
- Hospital stay ≥48h.
- Without IHCA
- Hospital stay ≥48h
Who cannot join
- <14 years
- Do Not Resuscitat
- Patients hospitalized due to out-of-hospital cardiac arrest
- Cardiac arrest occurs during the operation
- The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.
- CONTROL group
- <14 years
- Leave hospital without medical advice
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Wentao Sang, 15153187102, 752318151@qq.com
Feng Xu, 18560083066, xufengsdu@126.com
About this study
Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.
- Conditions
- In-Hospital Cardiac Arrest
- Being tested
- no intervention
- Keywords
- Critically ill patients, In-Hospital Cardiac Arrest, Early recognition, Early warning score
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 |
|---|---|---|
| CA group | Patients with In-Hospital Cardiac Arrest Receives: Other: no intervention | |
| CONTROL group | Patients without In-Hospital Cardiac Arrest Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Cardiac Arrest
Cardiac arrest occurs during hospitalization
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670458
- Sponsor's protocol ID
- IHCA-EWS-QLH
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04670458
- Acronym / sponsor ID
- IHCA-EWS-QLH
- Conditions
- In-Hospital Cardiac Arrest
- Keywords
- Critically ill patients, In-Hospital Cardiac Arrest, Early recognition, Early warning score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Dec 2020 (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.
Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA group | – | Other: no interventionPatients with In-Hospital Cardiac Arrest |
| CONTROL group | – | Other: no interventionPatients without In-Hospital Cardiac Arrest |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in the intensive care unit (ICU, CCU, RICU, EICU, NCU and DICU) of Qilu Hospital of Shandong University from January 1, 2017 to October 31, 2019 were selected.
Key inclusion criteria (4 listed)
- Occurrence of IHCA
- Hospital stay ≥48h.
- Without IHCA
- Hospital stay ≥48h
Key exclusion criteria (8 listed)
- <14 years
- Do Not Resuscitat
- Patients hospitalized due to out-of-hospital cardiac arrest
- Cardiac arrest occurs during the operation
- The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.
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 | CA group, CONTROL group |
Primary outcome
In-Hospital Cardiac Arrest
Time frame: Day 2
Cardiac arrest occurs during hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
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 In-Hospital Cardiac Arrest, run by Qilu Hospital of Shandong University 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 4 inclusion and 8 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 17 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wentao Sang (15153187102, 752318151@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Cardiac Arrest (time frame: Day 2). 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 17 Dec 2020.