Subsyndromal Delirium in Intensive Care Unit

Completed

• Conditions: Delirium

• Registration Number: NCT03813459
• Lead Sponsor: Centro Hospitalar Lisboa Ocidental

Brief Summary

Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive impairment in comparison to delirium. To date there is no published consensus on SSD definitions and has been commonly reported as an intermediate stage between delirium and normal mental states.

SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).

The objective of this study is to identify subsyndromal delirium prevalence, the association between SSD and clinical outcomes and understanding the relationship between SSD and conversion to delirium.

The relevance of this study is understanding of subsyndromal delirium in ICU, namely the importance of early presentations of acute brain dysfunction in the patients outcome.

Detailed Description

SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients in Intensive Care Units, to assess subsyndromal delirium.

A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU). Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.

The investigators access three different groups of patients: non-delirium, delirium and subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying cause of delirium and SSD are included. In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF)).

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-01-13
• Study First Submitted QC: 2019-01-19
• Study First Posted: 2019-01-23
• Primary Completion: 2019-09-01
• Study Completion: 2020-03-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-11
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age ≥ 18 years;
2. Admission in Intensive care Unit

Exclusion Criteria

1. Primary neurological diagnosis, with Glasgow Coma Scale (GCS) <14 on ICU admission or in previous days;
2. Blindness or deafness;
3. Aphasia;
4. Inability to communicate in the native language of the country where the study is enrolled;
5. Death during the first 24 hours;
6. Limitation of therapeutic efforts in the Intensive Care Unit admission;
7. Refusal to participate;
8. Previous diagnosis of dementia or psychiatric illness;
9. Readmission in ICU;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	28 days	defined as number of days that patients survived in 28 days
Ventilation free days	28 days	defined has the number of days from day 1 to day 28 on which a patient breathed without assistance
Number of patients with conversion from subsyndromal delirium to delirium during the period of study	14 days	ICDSC performed 1 time per day and determine how subsyndromal delirium (ICDSC 1-3) can have conversion to delirium (ICDSC \>/=4).

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	24 months	days until ICU discharge
Hospital length of stay	24 months	days until ICU discharge

Trial Locations

Locations (1)

Maria Carolina Vieira Júlio Paulino; 🇵🇹 Lisboa, Portugal