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CompletedNCT03813459SubSynDUpdated Dec 14, 2021

Subsyndromal Delirium in Intensive Care Unit

An observational study in Delirium, sponsored by Centro Hospitalar Lisboa Ocidental. Completed at 1 site in Portugal. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by Centro Hospitalar Lisboa Ocidental · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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)).

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Conditions studied

  • Delirium

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Keywords

  • Delirium
  • Subsyndromal delirium
  • Intensive Care Unit
03

In context

Delirium

933 studies on the registry are indexed under Delirium; 190 are open to participants now.

This study's enrollment of 400 is above the median of 194 across 342 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Centro Hospitalar Lisboa Ocidental is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Intensive Care Unit patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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;
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • Subsyndromal delirium positive

    Presence of Subsyndromal delirium in Intensive Care patients

  • Delirium positive

    Presence of Delirium in Intensive Care patients

  • No delirium

    Non subsyndromal delirium or delirium in Intensive Care patients

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What researchers measure

Primary outcomes

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

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

    Time frame: 14 days

  2. Mortality

    defined as number of days that patients survived in 28 days

    Time frame: 28 days

  3. Ventilation free days

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

    Time frame: 28 days

Secondary outcomes

  1. ICU length of stay

    days until ICU discharge

    Time frame: 24 months

  2. Hospital length of stay

    days until ICU discharge

    Time frame: 24 months

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Study locations

1 site
  • Maria Carolina Vieira Júlio Paulino
    Lisboa, 1300-346, Portugal
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References and documents

Publications

  • Boettger S, Nunez DG, Meyer R, Richter A, Schubert M, Jenewein J. Subsyndromal delirium in the intensive care setting: Phenomenological characteristics and discrimination of subsyndromal delirium versus no and full-syndromal delirium. Palliat Support Care. 2018 Feb;16(1):3-13. doi: 10.1017/S1478951517000104. Epub 2017 Mar 6. PubMed 28262089 ↗
  • Brummel NE, Boehm LM, Girard TD, Pandharipande PP, Jackson JC, Hughes CG, Patel MB, Han JH, Vasilevskis EE, Thompson JL, Chandrasekhar R, Bernard GR, Dittus RS, Ely EW. Subsyndromal Delirium and Institutionalization Among Patients With Critical Illness. Am J Crit Care. 2017 Nov;26(6):447-455. doi: 10.4037/ajcc2017263. PubMed 29092867 ↗
  • Serafim RB, Soares M, Bozza FA, Lapa E Silva JR, Dal-Pizzol F, Paulino MC, Povoa P, Salluh JIF. Outcomes of subsyndromal delirium in ICU: a systematic review and meta-analysis. Crit Care. 2017 Jul 12;21(1):179. doi: 10.1186/s13054-017-1765-3. PubMed 28697802 ↗
  • Yamada C, Iwawaki Y, Harada K, Fukui M, Morimoto M, Yamanaka R. Frequency and risk factors for subsyndromal delirium in an intensive care unit. Intensive Crit Care Nurs. 2018 Aug;47:15-22. doi: 10.1016/j.iccn.2018.02.010. Epub 2018 Mar 30. PubMed 29606481 ↗
  • Corona A, Colombo R, Catena E. Early Identification of Subsyndromal Delirium in the Critically Ill: Don't Let the Delirium Rise! Crit Care Med. 2016 Mar;44(3):644-5. doi: 10.1097/CCM.0000000000001544. No abstract available. PubMed 26901554 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03813459
Lead sponsor
Centro Hospitalar Lisboa Ocidental
Collaborators
Orion Corporation, Orion Pharma
Responsible party
Maria Carolina Vieira Júlio Paulino (Principal Investigator, Centro Hospitalar Lisboa Ocidental) — Principal investigator
First posted
Jan 23, 2019
Start date
Aug 1, 2018
Primary completion
Sep 1, 2019
Completion
Mar 31, 2020
Last update
Dec 14, 2021

Study contacts

Maria C Paulino, MD
study director · Centro Hospitalar de Lisboa Ocidental

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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