DeliriumNCT04812041
Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU
An observational study of Delirium and Covid19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Aim: to investigate whether the 4C Mortality score, which measures the severity of COVID-19, and the CAM-ICU 7 score , which measures the severity of delirium, in ICU. To compare two scores in terms of the number of days without intubation and 28 day mortality rates in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Covid19, Intensive Care Unit Delirium
- What is being tested?
- CAM-ICU 7 score and 4C Mortality Score
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2021to 25 May 2021
- How long will I take part?
- 1 Month
- 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 hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.
Inclusion Criteria:Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study
Exclusion Criteria:there is no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06800
İsmail Aytac, +905056340369, aytacismail1972@gmail.com
About this study
Aim: to investigate whether the 4C Mortality score, which measures the severity of COVID-19, and the CAM-ICU 7 score , which measures the severity of delirium, in ICU. To compare two scores in terms of the number of days without intubation and 28 day mortality rates in ICU.
- Conditions
- Delirium, Covid19, Intensive Care Unit Delirium
- Being tested
- CAM-ICU 7 score, 4C Mortality Score
- Medical subject headings
- Delirium, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM-ICU 7 scoreOther
A 7-point rating scale (0-7) was derived from the CAM-ICU and RASS assessments 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
4C Mortality ScoreOther
4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters
| Study group | Role | What they receive |
|---|---|---|
| Intensive care unit delirium | Covid-19 patients in ICU are screened for delirium and rated the severity with CAM-ICU 7 scores. Receives: Other: CAM-ICU 7 score; Other: 4C Mortality Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
28 day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start21 Jan 2021
- Primary completion15 May 2021 (estimated)
- Study completion25 May 2021 (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 DeliriumStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- betül aytaç, MD, Study chair, ankara ch bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812041
- Sponsor's protocol ID
- E1-21-1461
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.
PubMed 28263192Knight SR, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Gupta R, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Noursadeghi M, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LC, Openshaw PJ, Baillie JK, Semple MG, Docherty AB, Harrison EM; ISARIC4C investigators. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. BMJ. 2020 Sep 9;370:m3339. doi: 10.1136/bmj.m3339.
PubMed 32907855
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU
- ClinicalTrials.gov ID
- NCT04812041
- Acronym / sponsor ID
- E1-21-1461
- Conditions
- Delirium, Covid19, Intensive Care Unit Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 25 May 2021 (estimated)
- First posted
- 23 Mar 2021 (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.
Aim: to investigate whether the 4C Mortality score, which measures the severity of COVID-19, and the CAM-ICU 7 score , which measures the severity of delirium, in ICU. To compare two scores in terms of the number of days without intubation and 28 day mortality rates in ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit delirium | – | Other: CAM-ICU 7 score, Other: 4C Mortality ScoreCovid-19 patients in ICU are screened for delirium and rated the severity with CAM-ICU 7 scores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.
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 |
|---|---|---|
| CAM-ICU 7 scoreA 7-point rating scale (0-7) was derived from the CAM-ICU and RASS assessments 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. | Other | Intensive care unit delirium |
| 4C Mortality Score4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters | Other | Intensive care unit delirium |
Primary outcome
28 day mortality
Time frame: 28 days
28 day mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Results publication: PubMed 28263192Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.
- Results publication: PubMed 32907855Knight SR, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Gupta R, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Noursadeghi M, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LC, Openshaw PJ, Baillie JK, Semple MG, Docherty AB, Harrison EM; ISARIC4C investigators. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. BMJ. 2020 Sep 9;370:m3339. doi: 10.1136/bmj.m3339.
- 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.
betül aytaç, MD study chair
ankara ch bilkent
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 Delirium and Covid19, run by Ankara City Hospital Bilkent 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?
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 23 Mar 2021. 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 ismail aytaç, MD (+905056340369, aytacismail1972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days). 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 NCT04812041, 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 23 Mar 2021.