Clinical trial NCT03813459: Subsyndromal Delirium in Intensive Care Unit
Official title: Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Subsyndromal delirium
Intensive Care Unit
Lead sponsor: Centro Hospitalar Lisboa Ocidental
Sponsor class: OTHER_GOV
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2019-01-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive Care Unit patients

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)).

Eligibility criteria: 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;

Primary outcomes:
measure: Number of patients with conversion from subsyndromal delirium to delirium during the period of study
timeFrame: 14 days
measure: Mortality
timeFrame: 28 days
measure: Ventilation free days
timeFrame: 28 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 24 months
measure: Hospital length of stay
timeFrame: 24 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Maria Carolina Vieira Júlio Paulino
Study officials:
affiliation: Centro Hospitalar de Lisboa Ocidental
name: Maria C Paulino, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.