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Trial record 4 of 7 for:    RORA

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

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ClinicalTrials.gov Identifier: NCT02673450
Recruitment Status : Withdrawn (Lack of lab ressources)
First Posted : February 4, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Stine Estrup, Zealand University Hospital

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.


Condition or disease
Delirium

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit. A Prospective Cohort Study.
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clock gene expression [ Time Frame: 24 hours ]
    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


Secondary Outcome Measures :
  1. Melatonin secretion [ Time Frame: 24 hours ]
    Association between secretion of melatonin at 6am, 10am, 2pm, 6pm, 10pm and 2am. Cosinor curve analysis (mesor, amplitude and acrophase) and incidence of delirium

  2. PER3 subtype [ Time Frame: 24 hours ]
    Association between PER3 subtype determination at 6am (PER3 4/4, PER3 4/5 and PER3 5/5) and incidence and duration of delirium

  3. Delirium type [ Time Frame: 24 hours ]
    Delirium type (hypoactive/hyperactive/mixed) associated to PER3 and expression pattern of clock genes and melatonin secretion

  4. Demographic variables [ Time Frame: 24 hours ]
    Age, gender, weight at admission associated to PER3 and expression pattern of clock genes and melatonin secretion

  5. Sedation [ Time Frame: 24 hours ]
    Infusion of propofol, dexmedetomidine, midazolam, sufentanil, remifentanil associated to PER3 and expression pattern of clock genes and melatonin secretion

  6. Disease severity [ Time Frame: 24 hours ]
    SAPS II score at admission associated to PER3 and expression pattern of clock genes and melatonin secretion

  7. Admission type [ Time Frame: 24 hours ]
    Type of admission (medical/acute surgical/elective surgical) associated to PER3 and expression pattern of clock genes and melatonin secretion

  8. Length of stay [ Time Frame: Up to 6 months ]
    Length of stay at ICU and hospital associated to PER3 and expression pattern of clock genes and melatonin secretion

  9. Number of ventilator days [ Time Frame: Up to 6 months ]
    Number of ventilator days at ICU and hospital associated to PER3 and expression pattern of clock genes and melatonin secretion

  10. ICU delirium [ Time Frame: Up to 6 months ]
    Delirium defined as positive CAM-ICU or treatment with antipsychotics


Biospecimen Retention:   Samples With DNA
21 ml of blood from each patient is kept in a biobank for 10 years


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients admitted to the ICU at Køge Hospital in the study period
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673450


Locations
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Denmark
Zealand University Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Study Chair: Ole Mathiesen, MD, PhD Køge Hospital

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Responsible Party: Stine Estrup, Ph.d. student MD, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02673450     History of Changes
Other Study ID Numbers: SE 2-16
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders