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Completed

NCT Number: NCT04218461

PREdiction of DELIRium in Medical ICU Patients

In intensive care unit (ICU) patients, the ability to predict delirium may help reduce its incidence, duration, and severity. The PREdiction of DELIRium in ICU (PRE-DELIRIC) model was recently developed for this purpose. Our aim was to test the PRE-DELIRIC model in the medical ICU.

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Key information

Conditions

Delirium Confusion Intensive Care Unit Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Demiroglu Bİlim University

Istanbul, Sisli, 34360, Turkey (Türkiye)

About this study

Delirium, a disturbance of consciousness with an acute onset and a variable course of impaired cognitive functioning, is common in patients admitted to the ICU. Several tools are available for assessing delirium in ICU patients, of which the confusion assessment method-intensive care unit (CAM-ICU) has the highest sensitivity and specificity.

Although several predictive models for non-intensive care patients exist, as well as one for older medical intensive care patients, no evidence based prediction model for general intensive care patients is available. Also the tools are not involved the metabolic parameters which cause delirium. Because of that the tool need to have biochemical parameters.

In the light of these information our aim is to validate the PRE-DELIRIC model in medical ICU in Turkish people.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be at the medical ICU
  • 18 and older years of age
  • predict to stay in the ICU over 24 hours
  • not to be pregnant
  • not to be breastfeeding
  • not to have dementia, alcoholism
  • have not previously received a diagnosis of delirium
  • have not communication problem
  • agree to participate to the study by patient's relatives

Exclusion criteria

  • younger than 18 years old
  • stay in the ICU less than 24 hours
  • be pregnant
  • breastfeeding
  • have dementia, alcoholism
  • previously received a diagnosis of delirium
  • have communication problem
  • not agree to participate to the study by patient's relatives

Treatment and study plan

PRE-DELIRIC model

Diagnostic Test

To predict delirium according to risk factors in the PRE-DELIRIC model

Primary outcomes

  1. Predict of delirium risk with questionnare

    Time frame: up to 20 weeks

    CAM-ICU will be used for defining the delirium risk. We define delirium as a minimum of one positive CAM-ICU screening during each patient's intensive care stay developed and validated for ICU patients, assesses 10 risk factors for delirium that are readily observable within the first 24 hours following ICU admission. CAM-ICU scale includes of four items. The items are about level of consciousness, assessment of attention, state of thought organization and following a simple command. In order to be diagnosed with delirium, the first two items and one of the third or fourth item must be in favor of delirium.

  2. Predict of delirium risk with questionnare 2

    Time frame: up to 20 weeks

    The PRE-DELIRIC model will be used for defining the delirium risk. The PRE-DELIRIC model developed and validated for ICU patients, assesses 10 risk factors for delirium that are readily observable within the first 24 hours following ICU admission. The model consists of biochemical parameters, used drugs, infection status.

  3. Comparison of delirium risk with two questionnares

    Time frame: up to 20 weeks

    The investigator will assess the CAM-ICU and PRE-DELIRIC in the first 24 hours after the patient comes to the ICU. The PRE-DELIRIC model and CAM-ICU will use for defining the deliirum risk. The investigators will do validity and reliability of PRE-DELIRIC model in medical ICU patients.

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

Evaluation of the Usability of the Delirium Prediction Model of PRE-DELIRIC (PREdiction of DELIRium) in Medical ICU Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2020
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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