SubSynD: Subsyndromal Delirium in Intensive Care Unit
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subsyndromal delirium positive Presence of Subsyndromal delirium in Intensive Care patients |
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| Delirium positive Presence of Delirium in Intensive Care patients |
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| No delirium Non subsyndromal delirium or delirium in Intensive Care patients |
Outcome Measures
Primary Outcome Measures
- 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).
- 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
Secondary Outcome Measures
- ICU length of stay [24 months]
days until ICU discharge
- Hospital length of stay [24 months]
days until ICU discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years;
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Admission in Intensive care Unit
Exclusion Criteria:
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Primary neurological diagnosis, with Glasgow Coma Scale (GCS) <14 on ICU admission or in previous days;
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Blindness or deafness;
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Aphasia;
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Inability to communicate in the native language of the country where the study is enrolled;
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Death during the first 24 hours;
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Limitation of therapeutic efforts in the Intensive Care Unit admission;
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Refusal to participate;
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Previous diagnosis of dementia or psychiatric illness;
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Readmission in ICU;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maria Carolina Vieira Júlio Paulino | Lisboa | Portugal | 1300-346 |
Sponsors and Collaborators
- Centro Hospitalar Lisboa Ocidental
- Orion Corporation, Orion Pharma
Investigators
- Study Director: Maria C Paulino, MD, Centro Hospitalar de Lisboa Ocidental
Study Documents (Full-Text)
None provided.More Information
Publications
- Boettger S, Nuñez 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.
- 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.
- 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.
- 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. Review.
- 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.
- UCIP1