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Completed

NCT Number: NCT03813459

Subsyndromal Delirium in Intensive Care Unit

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Carolina Vieira Júlio Paulino

Lisbon, 1300-346, Portugal

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Admission in Intensive care Unit

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of patients with conversion from subsyndromal delirium to delirium during the period of study

    Time frame: 14 days

    ICDSC performed 1 time per day and determine how subsyndromal delirium (ICDSC 1-3) can have conversion to delirium (ICDSC >/=4).

  2. Mortality

    Time frame: 28 days

    defined as number of days that patients survived in 28 days

  3. Ventilation free days

    Time frame: 28 days

    defined has the number of days from day 1 to day 28 on which a patient breathed without assistance

Secondary outcomes

  1. ICU length of stay

    Time frame: 24 months

    days until ICU discharge

  2. Hospital length of stay

    Time frame: 24 months

    days until ICU discharge

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Lisboa Ocidental

Other Gov

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study

Acronym: SubSynD

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 23, 2019
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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