Subsyndromal Delirium in Intensive Care Unit

NCT03813459 | Completed

• 1 other identifier: UCIP1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Delirium; Subsyndromal delirium; Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• 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

• Mortality

  defined as number of days that patients survived in 28 days

  28 days

• 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 Outcomes (2)

• ICU length of stay

  24 months

• Hospital length of stay

  24 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intensive Care Unit patients

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centro Hospitalar Lisboa Ocidental: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

Maria Carolina Vieira Júlio Paulino

Lisbon, 1300-346, Portugal

Location

Related Publications (5)

• 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.

  PMID: 28262089 BACKGROUND

• 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.

  PMID: 29092867 BACKGROUND

• 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.

  PMID: 28697802 BACKGROUND

• 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.

  PMID: 29606481 BACKGROUND

• 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.

  PMID: 26901554 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria C Paulino, MD

  Centro Hospitalar de Lisboa Ocidental

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 23, 2019
• Study Start: August 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 31, 2020
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

PT (1)