Trial document




drksid header

  DRKS00016951

Trial Description

start of 1:1-Block title

Title

The Confusion Assessment Method and the 4AT in older patients on the intensive care unit: prevalence of delirium and its implication for prognosis

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Delirium@ICU

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A delirium is a disease, that - among other symptoms - impairs consciousness and affects a large percentage of patients in intensive care units. Often it remains undetected. We now want to find out how often delirium occurs in our patients older than 65 hospitalized during 6 months in our intensive and intermediate care unit. We have chosen already validated instruments (CAM-ICU and 4AT) as screening tools. Using a comprehensive geriatric assessment, we will calculate the MPI (multidimensional prognostic index) to ascertain the implications of delirium and geriatric syndroms for the patients. In addition, we will measure life quality using the EQ-5D-5L. All of the tests mentioned above are questionnaires and can be conducted with direct patient contact. One and three months after recruitment we will contact the patients again and conduct a geriatric follow-up as well as ask for life-quality again.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Delirium occurs frequently in patients hospitalized in intensive care units. Since many units have not yet incorporated a standardized screening method and as particularly the hypokinetic delirium often proceeds in an unapparent manner, it is frequently unrecognized and therefore remains untreated. Unfortunately a delirium impairs the patient's prognosis, extends hospitalization time, increases costs and is a risk factor for developing dementia. As a form of quality management we now want to find out how often delirium occurs in our patients older than 65 hospitalized during 6 months in our intensive and intermediate care unit.
We have chosen already validated instruments (CAM-ICU and 4AT) as screening tools. Using a comprehensive geriatric assessment, we will calculate the MPI (multidimensional prognostic index) to ascertain the implications of delirium and geriatric syndroms for the patients. In addition, we will measure life quality using the EQ-5D-5L. All of the tests mentioned above are questionnaires and can be conducted with direct patient contact. One and three months after recruitment we will contact the patients again and conduct a geriatric follow-up as well as ask for life-quality again.

*Amendment 8.9.2019: Patients will be recruited for a period of 6 instead of initially 3 months. Number of recruited patients will be about 100 instead of 50.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

No sharing of patient data planned (01/2020)

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016951
  •   2019/05/06
  •   [---]*
  •   yes
  •   Approved
  •   19-1049_1, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F05 -  Delirium, not induced by alcohol and other psychoactive substances
  •   GERIATRISCHESYNDROME
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients older than 65 hospitalized during 6 months in intensive or intermediate care will be screened daily for delirium using the CAM-ICU and 4AT. A comprehensive geriatric assessment will be conducted once to calculate the multidimensional prognostic index (MPI). Life-quality will be evaluated once using the EQ-5D-5L. After one and three months we will do a follow-up to acquire information regarding health, life-situation and life-quality.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Occurrence of delirum
- MPI (multidimensional prognostic index)
Measurement once at recruitment. The study ends 3 months after last recruitment.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Use of outpatient care
- Home delivery
- Number of drugs
- Hospitalization rate
- Mortality
- Geriatric syndromes
- Geriatric resources
- Life-quality
- Parenteral nutrition
- Use of diagnostic procedures
- Further treatment/consultation

Measurement once during recruitment conducting a geriatric assessment (CGA) and using EQ-5D-5L (life-quality) as well as 1 and 3 months after recruitment by telephone interview.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/07/16
  •   110
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1) Patient is older than 65 when being recruted

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1) Patient is younger than 65
2) Patient does not speak german well enough to participate accordingly
3) Patient has been hospitalized in intensive or intermediate care more than 48 hours ago
4) Patient is being ventilated mechanically
5) Patient is in need for intermediate medical intervention due to a life-threatening circumstance
6) Patient does not comply inclusion criteria

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Köln - Zentrum Innere Medizin
    • Ms.  Prof. Dr. Dr.  Maria Cristina  Polidori Nelles 
    • Herderstr. 52
    • 50937  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik II für Innere Medizin, Uniklinik Köln, Klinische Altersforschung
    • Mr.  Nick Alexander  Nolting 
    • Herderstr. 52
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik II für Innere Medizin, Uniklinik Köln, Klinische Altersforschung
    • Ms.  Prof. Dr. Dr.   Maria Cristina  Polidori Nelles 
    • Herderstr. 52
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Uniklinik Köln - Zentrum Innere Medizin
    • Ms.  Prof. Dr. Dr.  Maria Cristina  Polidori Nelles 
    • Herderstraße 52
    • 50937  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Votum
  •   Studienplan
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.