Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU

Covid19 Clinical Trial

Official title:

Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04812041
• Other study ID #: E1-21-1461
• Status: Recruiting
• Start date: January 21, 2021
• Est. completion date: May 25, 2021

Study information

• Verified date: March 2021
• Source: Ankara City Hospital Bilkent
• Contact: ismail aytaç, MD
• Phone: +905056340369
• Email: aytacismail1972[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 25, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Delirium
• Intensive Care Unit Delirium

Intervention

Other:
• CAM-ICU 7 score
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 Score
4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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: — View Citation

Knight 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day mortality	28 day mortality	28 days