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

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Recruiting

CT.gov ID

NCT04812041

Collaborator

(none)

150

Enrollment

Location

4.1

Anticipated Duration (Months)

36.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Delirium Covid19 Intensive Care Unit Delirium	Other: CAM-ICU 7 score Other: 4C Mortality Score

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 21, 2021

Anticipated Primary Completion Date :

May 15, 2021

Anticipated Study Completion Date :

May 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Intensive care unit delirium Covid-19 patients in ICU are screened for delirium and rated the severity with CAM-ICU 7 scores.	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. Other: 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

Arm

Intervention/Treatment

Intensive care unit delirium

Covid-19 patients in ICU are screened for delirium and rated the severity with CAM-ICU 7 scores.

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.

Other: 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

Outcome Measures

Primary Outcome Measures

28 day mortality [28 days]
28 day mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey	06800

Sponsors and Collaborators

Ankara City Hospital Bilkent

Investigators

Study Chair: betül aytaç, MD, ankara ch bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ismail aytaç, medical doctor, Ankara City Hospital Bilkent

ClinicalTrials.gov Identifier:

NCT04812041

Other Study ID Numbers:

E1-21-1461

First Posted:

Mar 23, 2021

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Delirium

Study Results

No Results Posted as of Mar 23, 2021