Early Clinical DeteriorationNCT03910777
Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge
An observational study of Early Clinical Deterioration and Early Warning Score, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
The VitalPac Early Warning Score (VIEWS) scoring system, developed by Prytherch et al., Is an early warning system that aims to predict the first 24-hour mortality in emergency patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Clinical Deterioration, Early Warning Score
- What is being tested?
- Early Warning Score
- How many people
- 390 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 15 Jan 2020
- How long will I take part?
- 6 Months
- 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: 390 patients who were discharged from the intensive care unit over the age of 18 and who were taken back within 24 hours will be included.
Who may be able to join
- over 18 years,
- discharged from the ICU and returned within 24 hours
Who cannot join
- under 18 years old, postoperative patients, pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzincan University
Erzincan, 24100
ufuk kuyrukluyıldız, +904462122222, drufuk2001@gmail.com
ilke kupeli
About this study
The VitalPac Early Warning Score (VIEWS) scoring system, developed by Prytherch et al., Is an early warning system that aims to predict the first 24-hour mortality in emergency patients.
National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients.
The aim of this study was to determine the early clinical deterioration after ICU and hence the rate of admission to intensive care and to evaluate whether these two scoring systems can be used to determine early clinical deterioration in intensive care early discharge.
- Conditions
- Early Clinical Deterioration, Early Warning Score
- Being tested
- Early Warning Score
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Warning ScoreDiagnostic test
National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients recovered due to early clinical deterioration within the first 24 hours after ICU discharge
The aim of this study is to determine the early clinical deterioration in the first 24 hours after ICU discharge and therefore the rate of admission to ICU.
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion15 Jan 2020 (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 Early Clinical DeteriorationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910777
- Sponsor's protocol ID
- EBYU 2
- Status last verified
- Jul 2019
- First submitted
- 8 Apr 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uppanisakorn S, Bhurayanontachai R, Boonyarat J, Kaewpradit J. National Early Warning Score (NEWS) at ICU discharge can predict early clinical deterioration after ICU transfer. J Crit Care. 2018 Feb;43:225-229. doi: 10.1016/j.jcrc.2017.09.008. Epub 2017 Sep 13.
PubMed 28926736Cardoso FS, Karvellas CJ, Kneteman NM, Meeberg G, Fidalgo P, Bagshaw SM. Respiratory rate at intensive care unit discharge after liver transplant is an independent risk factor for intensive care unit readmission within the same hospital stay: a nested case-control study. J Crit Care. 2014 Oct;29(5):791-6. doi: 10.1016/j.jcrc.2014.03.038. Epub 2014 Apr 24.
PubMed 24857401
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge
- ClinicalTrials.gov ID
- NCT03910777
- Acronym / sponsor ID
- EBYU 2
- Conditions
- Early Clinical Deterioration, Early Warning Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 10 Apr 2019 (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 VitalPac Early Warning Score (VIEWS) scoring system, developed by Prytherch et al., Is an early warning system that aims to predict the first 24-hour mortality in emergency patients.
National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients.
The aim of this study was to determine the early clinical deterioration after ICU and hence the rate of admission to intensive care and to evaluate whether these two scoring systems can be used to determine early clinical deterioration in intensive care early discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 390 patients who were discharged from the intensive care unit over the age of 18 and who were taken back within 24 hours will be included.
Key inclusion criteria (2 listed)
- over 18 years,
- discharged from the ICU and returned within 24 hours
Key exclusion criteria (1 listed)
- under 18 years old, postoperative patients, pregnant women
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 |
|---|---|---|
| Early Warning ScoreNational early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients | Diagnostic test | – |
Primary outcome
Number of patients recovered due to early clinical deterioration within the first 24 hours after ICU discharge
Time frame: six month
The aim of this study is to determine the early clinical deterioration in the first 24 hours after ICU discharge and therefore the rate of admission to ICU.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Results publication: PubMed 28926736Uppanisakorn S, Bhurayanontachai R, Boonyarat J, Kaewpradit J. National Early Warning Score (NEWS) at ICU discharge can predict early clinical deterioration after ICU transfer. J Crit Care. 2018 Feb;43:225-229. doi: 10.1016/j.jcrc.2017.09.008. Epub 2017 Sep 13.
- Results publication: PubMed 24857401Cardoso FS, Karvellas CJ, Kneteman NM, Meeberg G, Fidalgo P, Bagshaw SM. Respiratory rate at intensive care unit discharge after liver transplant is an independent risk factor for intensive care unit readmission within the same hospital stay: a nested case-control study. J Crit Care. 2014 Oct;29(5):791-6. doi: 10.1016/j.jcrc.2014.03.038. Epub 2014 Apr 24.
- 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.
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 Early Clinical Deterioration and Early Warning Score, run by Erzincan University at 1 site in Turkey (Türkiye).
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 1 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 Jul 2019. 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 Turkey (Türkiye). 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 ilke kupeli (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients recovered due to early clinical deterioration within the first 24 hours after ICU discharge (time frame: six month). 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 NCT03910777, 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 17 Jul 2019.