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

NCT04812041 | Unknown

• 1 other identifier: E1-21-1461
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Covid19; Intensive Care Unit Delirium

Outcome Measures

Primary Outcomes (1)

• 28 day mortality

  28 day mortality

  28 days

Study Arms (1)

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; Other: 4C Mortality Score

Interventions

CAM-ICU 7 score OTHER

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.

Intensive care unit delirium

4C Mortality Score OTHER

4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters

Intensive care unit delirium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related 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: 10.1097/CCM.0000000000002368.

  PMID: 28263192 RESULT

• 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, 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.

  PMID: 32907855 RESULT

MeSH Terms

Conditions

Delirium; COVID-19

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• betül aytaç, MD

  ankara ch bilkent

  STUDY CHAIR

Central Study Contacts

ismail aytaç, MD

CONTACT

+905056340369; aytacismail1972@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 23, 2021
• Study Start: January 21, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 25, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

TU (1)