PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.

NCT02673450 | Withdrawn DMC

• 1 other identifier: SE 2-16
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates a possible relationship between disturbance of the cyclic expression of ten different clock genes and development of delirium in patients admitted to an intensive care unit It also investigates a possible relationship between disturbance of the cyclic expression of melatonin and development of delirium in patients admitted to an intensive care unit. Finally a possible relationship between genetic differences in the PER3 gene and development of delirium is investigated.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Clock gene expression

  Association between expression of clock genes (Clock, Cry1-2, Per1-3, Rorα, Bmal1, Rev-erb and CSNK1ε) (measured at 6am, 10am, 2pm, 6pm, 10pm and 2am) and incidence of delirium at the ICU

  24 hours

Secondary Outcomes (10)

• Melatonin secretion

  24 hours

• PER3 subtype

  24 hours

• Delirium type

  24 hours

• Demographic variables

  24 hours

• Sedation

  24 hours

Eligibility Criteria

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

Study Population

Adult patients admitted to the ICU at Køge Hospital in the study period

You may qualify if:

• Patients \>18 years of age admitted to the ICU at Køge Hospital in the study period

You may not qualify if:

• Not able to speak or understand Danish
• Melatonin (ATC N05CH01) or melatonin agonist (ATC N06AX) treatment prior to admission
• Known insomnia (daily hypnotic (ATC N05C) consumption or known sleep disorder)
• Patients discharged from the ICU during the test period (time from first to last blood sample)
• Patients who die during the test period
• Patients transferred to another hospital during ICU stay

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

21 ml of blood from each patient is kept in a biobank for 10 years

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

• Ole Mathiesen, MD, PhD

  Køge Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d. student MD

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 4, 2016
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)