Subsyndromal Delirium in Intensive Care Unit

Delirium Clinical Trial

— SubSynD  

Official title:

Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813459
• Other study ID #: UCIP1
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2021
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 31, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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;

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Portugal	Maria Carolina Vieira Júlio Paulino	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 days
Primary	Mortality	defined as number of days that patients survived in 28 days	28 days
Primary	Ventilation free days	defined has the number of days from day 1 to day 28 on which a patient breathed without assistance	28 days
Secondary	ICU length of stay	days until ICU discharge	24 months
Secondary	Hospital length of stay	days until ICU discharge	24 months