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Completed

NCT Number: NCT02518646

DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models

Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet implemented as standard in clinical practice, as it is unknown which delirium prediction model can best be used to predict delirium in ICU patients.Therefore the main aim of this study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Netherlands

About this study

Delirium often occurs in ICU patients and is associated with negative consequences, requiring prevention. A prediction model facilitates the identification of those patients at risk for delirium and therefore need prevention the most. At present, two ICU delirium prediction models are available. First the PRE-DELIRIC model was developed. This recently recalibrated model reliably predicts ICU patients' risk for delirium within 24 hours after ICU admission. Because a relevant number of patients develops delirium during the first 24 hours after ICU admission, and prevention ideally should be deployed as soon as possible, the investigators developed the 'early prediction model' (E-PRE-DELIRIC) which reliably predicts delirium immediately after ICU admission. To implement a delirium prediction model in clinical practice, one needs to know which model best can be used. Currently, the use of a delirium prediction model is not implemented as standard in clinical practice, as this information is unavailable. Therefore the main aim of this study is to compare the (predictive and clinical) performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICU patients aged ≥18 years;
  • Surgical, medical, neurology/neurosurgical, or trauma patients.

Exclusion criteria

  • Delirious at ICU admission;
  • Expected ICU stay shorter than 6 hours;
  • Unable to reliably assess ICU delirium due to:
  • sustained coma during entire ICU stay;
  • unable to understand the language spoken;
  • severely mentally disabled;
  • serious receptive aphasia;
  • serious auditory or visual disorders.

Treatment and study plan

Primary outcomes

  1. Development of ICU delirium

    Time frame: During the first 14 days after ICU admission

    Defined as a positive assessment for delirium and/or when a patient is treated with haloperidol or other anti-psychotics for delirium (and unable to be assessed).

Secondary outcomes

  1. Delirium subtype

    Time frame: During the first 14 days after ICU admission

    Hyperactive delirium is defined as patients with a persistent positive RASS assessment during the delirium episode (+1 to +4).

    Hypoactive delirium is defined as patients with a persistent neutral or negative RASS assessment during the delirium episode (0 to -3).

    Mixed delirium is defined as patients with both positive and negative RASS assessments during the delirium episode. (Peterson 2006)

  2. Delirium duration

    Time frame: During the first 14 days after ICU admission

    The duration of delirium is defined as time (in days) from the first positive CAM-ICU/ICDSC or treatment with haloperidol or other anti-psychotics for delirium, until the beginning of two consecutive days of negative delirium screenings (negative CAM-ICU/ICDSC).

  3. Delirium episodes

    Time frame: During the first 14 days after ICU admission

    Defined as the number of episodes a patient is screened positive for delirium. A delirium episode is defined as the time from first the positive delirium assessment, until the beginning of two consecutive days (48 hours) of negative delirium assessments.

  4. Delirium onset in a specified period

    Time frame: During the first 14 days after ICU admission

    Based on the quartiles of the time to development of delirium at: day 0-1; day 2; day 3-6; >day 6. These quartiles are based on a former delirium prediction study (E-PRE-DELIRIC). (Wassenaar 2015)

  5. Development of delirium

    Time frame: During the first 14 days after ICU admission

    Defined as ≥ 2 positive assessments for delirium within 48 hours (because of the fluctuating course of delirium).

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: DECISION

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2015
Registry last updated
May 19, 2017

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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