Early Clinical DeteriorationNCT03912701
Early Warning Systems, Risk of Early Clinical Deterioration
An observational study of Early Clinical Deterioration, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
Primary purpose of the study was to evaluate the relationship between "NEWS" and "VIEWS" scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Clinical Deterioration
- What is being tested?
- Vitalpac early warning score (VIEWS)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 15 Nov 2019
- 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: Patients over the age of 18 and discharged and admitted to intensive care in the first 24 hours
Who may be able to join
- over 18 years
- patients who were taken back to the intensive care unit in the first 24 hours
Who cannot join
- under 18 years old,
- patients undergoing postoperative intensive care,
- 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
Official title: If Early Warning Systems Were Used, Could the Risk of Early Clinical Deterioration be Predicted and Re-admission to Intensive Care Could be Prevented
Primary purpose of the study was to evaluate the relationship between "NEWS" and "VIEWS" scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality.
- Conditions
- Early Clinical Deterioration
- Being tested
- Vitalpac early warning score (VIEWS)
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitalpac early warning score (VIEWS)Diagnostic test
The Vitalpac early warning score (ViEWS) is an early warning system aimed primarily at prediction of the first 24-hour mortality in emergency patients and has not been used to assess intensive care unit discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who were taken back to intensive care unit due to early clinical deterioration
Number of patients who were taken back to intensive care unit due to early clinical deterioration
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 posted11 Apr 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
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
- NCT03912701
- Sponsor's protocol ID
- EBYU 3
- Status last verified
- Jul 2019
- First submitted
- 9 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
- Undecided
Publications
Kaben A, Correa F, Reinhart K, Settmacher U, Gummert J, Kalff R, Sakr Y. Readmission to a surgical intensive care unit: incidence, outcome and risk factors. Crit Care. 2008;12(5):R123. doi: 10.1186/cc7023. Epub 2008 Oct 6.
PubMed 18838006Prytherch DR, Smith GB, Schmidt PE, Featherstone PI. ViEWS--Towards a national early warning score for detecting adult inpatient deterioration. Resuscitation. 2010 Aug;81(8):932-7. doi: 10.1016/j.resuscitation.2010.04.014.
PubMed 20637974McGinley A, Pearse RM. A national early warning score for acutely ill patients. BMJ. 2012 Aug 8;345:e5310. doi: 10.1136/bmj.e5310. No abstract available.
PubMed 22875955
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
- If Early Warning Systems Were Used, Could the Risk of Early Clinical Deterioration be Predicted and Re-admission to Intensive Care Could be Prevented
- ClinicalTrials.gov ID
- NCT03912701
- Acronym / sponsor ID
- EBYU 3
- Conditions
- Early Clinical Deterioration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 11 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.
Primary purpose of the study was to evaluate the relationship between "NEWS" and "VIEWS" scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 and discharged and admitted to intensive care in the first 24 hours
Key inclusion criteria (2 listed)
- over 18 years
- patients who were taken back to the intensive care unit in the first 24 hours
Key exclusion criteria (3 listed)
- under 18 years old,
- patients undergoing postoperative intensive care,
- 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 |
|---|---|---|
| Vitalpac early warning score (VIEWS)The Vitalpac early warning score (ViEWS) is an early warning system aimed primarily at prediction of the first 24-hour mortality in emergency patients and has not been used to assess intensive care unit discharge. | Diagnostic test | – |
Primary outcome
Number of patients who were taken back to intensive care unit due to early clinical deterioration
Time frame: six month
Number of patients who were taken back to intensive care unit due to early clinical deterioration
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.
- Background: PubMed 18838006Kaben A, Correa F, Reinhart K, Settmacher U, Gummert J, Kalff R, Sakr Y. Readmission to a surgical intensive care unit: incidence, outcome and risk factors. Crit Care. 2008;12(5):R123. doi: 10.1186/cc7023. Epub 2008 Oct 6.
- Results publication: PubMed 20637974Prytherch DR, Smith GB, Schmidt PE, Featherstone PI. ViEWS--Towards a national early warning score for detecting adult inpatient deterioration. Resuscitation. 2010 Aug;81(8):932-7. doi: 10.1016/j.resuscitation.2010.04.014.
- Results publication: PubMed 22875955McGinley A, Pearse RM. A national early warning score for acutely ill patients. BMJ. 2012 Aug 8;345:e5310. doi: 10.1136/bmj.e5310. No abstract available.
- Individual participant dataSharing planned: Undecided
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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, 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 3 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 who were taken back to intensive care unit due to early clinical deterioration (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 NCT03912701, which also lists 3 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.