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The EARLY DELTA Trial (EARLY DELTA)

Primary Purpose

Delirium, Critical Illness, Acute Encephalopathy

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
DeltaScan
Sponsored by
Thomas Ottens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium focused on measuring acute encephalopathy, delirium, critical illness, intensive care unit, automated EEG, electroencephalography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (18 years or above) admitted to ICU for any indication
  • ICU length of stay anticipated to be 48h or longer from time of screening for inclusion
  • Written informed consent by patient or representative

Exclusion Criteria:

  • More than 96 hours have elapsed since ICU admission
  • Patient or representative decline participation
  • Admission for out-of-hospital cardiac arrest, status epilepticus, hemorrhagic or ischemic stroke, increased intracranial pressure, isolated head trauma
  • Recent intracranial neurosurgery (<30 days prior to inclusion)
  • Known space-occupying lesions in the brain or skull
  • Metal implants in brain or skull
  • Diagnosis of dementia or Parkinson's disease
  • Inpatient from nursing home
  • Lithium use (<30 days prior to inclusion)
  • Imminent death or palliative care phase
  • Patients ánd their legal representatives both do not understand Dutch or English
  • Patients who participated in the EARLY DELTRA trial <90 days ago

Sites / Locations

  • Medisch Spectrum Twente
  • HagaZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Usual Care

Usual Care + DeltaScan

Arm Description

Usual care group. Participants undergo twice daily DeltaScan measurements in addition to usual care. An adapted device is used, that masks the measurement result (it generates a QR-code, that is scanned into the patient data management system). The results will be unblinded one enrollment is complete.

Intervention group. Participants undergo twice daily DeltaScan measurements in addition to usual care. The measurement result is used together with routine delirium screening observations to guide management, according to the local delirium protocol.

Outcomes

Primary Outcome Measures

ICU length of stay
Length of stay in the intensive care unit, measured in hours

Secondary Outcome Measures

Encephalopathy/delirium occurrence (DeltaScan)
Defined as: any DeltaScan score ≥ 3 OR initiation of antipsychotic treatment
Delirium occurrence (ICDSC)
Defined as: any ICDSC score ≥ 4 OR initiation of antipsychotic treatment
ICU encephalopathy/delirium and coma free days (reported as: composite, delirium free days, coma free days)
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without delirium or coma. We will calculate this value separately based on DeltaScan alone, DeltaScan+ICDSC and ICDSC alone)
ICU ventilator free days
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without mechanical ventilation, regardless of ventilation mode or route. High-flow nasal oxygen (HFNO) will not be regarded as ventilation. If patients are ventilated with a device provided by another institute (i.e. Centrum voor Thuisbeademing), only days spent on the ICU ventilator will be counted. Any day with <12h of mechanical ventilation will be counted as 0,5 day. More than 12h of mechanical ventilation will be counted as 1 day
ICU organ support free days
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without mechanical ventilation (any modality), HFNO, renal replacement therapy (any modality), mechanical circulatory support (ECLS, IABP, Impella), intravenous inotropes (dobutamine, milrinone, enoximone, levosimendan) or vasopressors (noradrenalin > 0.25 mcg/kg/min or any dose of terlipressin / arginine vasopressin)
ICU mortality rate
Defined as death occurring before ICU discharge. Outcome reported as proportion of participants who died before ICU discharge.
ICU readmission rate
Unplanned re-admission to the ICU before hospital discharge. Outcome reported as proportion of participants who were re-admitted to ICU before hospital discharge.
Hospital length-of-stay
Outcome reported in days
Hospital mortality rate
Defined as death occurring before hospital discharge. Outcome reported as proportion of participants who died before hospital discharge.
90 day mortality rate
Defined as death occurring within 90 days after study enrollment. Outcome reported as proportion of participants who died before 90d follow-up
ICU Sedative Drug requirement
The cumulative doses of the following sedative drugs, administered after randomisation: propofol, clonidine, dexmedetomidine, esketamine, zopiclone, benzodiazepines
ICU opioid requirement
The cumulative doses of opioids, administered after randomisation
ICU antipsychotic drug requirement
cumulative dose of the following antipsychotic drugs, administered after randomisation: haloperidol, quetiapine, other antipsychotic drugs
ICU accidental device removal incidence and falls
Defined as the number of incidents where a patient accidentally removes an indwelling catheter, tube, infusion line or drain (e.g. intravenous lines, wound drains, airway device, feeding tubes etc) or falls out of bed
ICU incidence and duration of the use of physical restraints
Defined as the frequency of application of physical restraints and the cumulative duration of restraint application during ICU admission
Self-assessed quality of life
Self-assessed quality of life measured with the Euroqol Quality of Life questionnaire, version EQ6D
Self assessed cognitive function
Self-assessed cognitive function measured with the cognitive failure questionnaire (CFQ, Merckelbach, Muris & Nijman 1996)
Self assessed mood and depression symptoms
Self assessed mood and depression symptoms measured with the Patient Health Questionnaire (PHQ-9)
Self assessed mobility and physical functioning
Self assessed mobility and physical functioning measured with the Barthel Index

Full Information

First Posted
May 13, 2022
Last Updated
July 25, 2023
Sponsor
Thomas Ottens
Collaborators
Prolira, Dutch Society of Intensive Care
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1. Study Identification

Unique Protocol Identification Number
NCT05403268
Brief Title
The EARLY DELTA Trial
Acronym
EARLY DELTA
Official Title
The Impact of Early Delirium Detection With DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
March 2, 2025 (Anticipated)
Study Completion Date
March 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Ottens
Collaborators
Prolira, Dutch Society of Intensive Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Rationale: Delirium is a type of acute encephalopathy that is triggered by an underlying somatic disorder. Patients experience disturbances in attention, alertness and other cognitive functions. In patients with delirium, a characteristic electroencephalography (EEG) pattern is seen, known as polymorphic delta activity. The MDR certified medical device "Deltascan" can detect this EEG pattern. Traditional clinical delirium screening instruments are known to have limited sensitivity, in particular for detecting hypoactive delirium. We hypothesize that adding EEG based encephalopathy detection to clinical observation scales increases the sensitivity and results in earlier detection of delirium and subsyndromal delirium, resulting in improved clinical outcomes of critically ill patients, such as delirium duration, ICU length of stay or survival. Objective: This randomized controlled trial aims to study the effect of implementation of EEG based encephalopathy detection (DeltaScan, Prolira, Utrecht, The Netherlands, hereafter: DeltaScan) on relevant clinical endpoints (ICU length of stay, sedative requirements and delirium related complications, among others) in a mixed medical and surgical intensive care unit population. Study design: a randomized controlled trial Study population: adult patients (>18 years) admitted to the ICU for unplanned care with a minimal anticipated ICU length of stay of 48h. Intervention: either usual care, where the patients' medical team obtains regular delirium screening, versus usual care plus twice daily DeltaScan measurements. During the daily medical rounds, the DeltaScan results will be presented to the patients' medical team together with decision support, consisting of DeltaScan trend interpretation and protocol-based suggestions for evaluation of underlying delirium cause. Main study parameters/endpoints: primary endpoint will be ICU length of stay. Secondary endpoints are encephalopathy/delirium occurrence, ICU encephalopathy/delirium free days, ventilator free days, organ support free days, sedative, opioid and antipsychotic drug requirement, delirium related complication occurrence, frequency and duration of physical restraints application, ICU mortality, ICU readmission, hospital length of stay, hospital mortality and 90-day mortality. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, it is not expected that randomization to the intervention group adds risk for patients. This is a study of a diagnostic intervention with additional encephalopathy/delirium observations consisting of a short (90 seconds) EEG measurement, which does not harm the patient. Clinicians will receive protocol-based decision support alongside the diagnostic observation. No additional medical treatments will be conducted as part of the study protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Critical Illness, Acute Encephalopathy
Keywords
acute encephalopathy, delirium, critical illness, intensive care unit, automated EEG, electroencephalography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with 2 parallel arms: control group (usual care) and intervention group.
Masking
None (Open Label)
Masking Description
Usual care group undergoes DeltaScan measurements with blinded device to prevent the measurement result from influencing clinical decisions.
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Description
Usual care group. Participants undergo twice daily DeltaScan measurements in addition to usual care. An adapted device is used, that masks the measurement result (it generates a QR-code, that is scanned into the patient data management system). The results will be unblinded one enrollment is complete.
Arm Title
Usual Care + DeltaScan
Arm Type
Experimental
Arm Description
Intervention group. Participants undergo twice daily DeltaScan measurements in addition to usual care. The measurement result is used together with routine delirium screening observations to guide management, according to the local delirium protocol.
Intervention Type
Device
Intervention Name(s)
DeltaScan
Other Intervention Name(s)
automated 1-channel EEG
Intervention Description
Twice daily DeltaScan observations
Primary Outcome Measure Information:
Title
ICU length of stay
Description
Length of stay in the intensive care unit, measured in hours
Time Frame
Assessed at the 90 day post discharge follow-up
Secondary Outcome Measure Information:
Title
Encephalopathy/delirium occurrence (DeltaScan)
Description
Defined as: any DeltaScan score ≥ 3 OR initiation of antipsychotic treatment
Time Frame
Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
Delirium occurrence (ICDSC)
Description
Defined as: any ICDSC score ≥ 4 OR initiation of antipsychotic treatment
Time Frame
Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
ICU encephalopathy/delirium and coma free days (reported as: composite, delirium free days, coma free days)
Description
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without delirium or coma. We will calculate this value separately based on DeltaScan alone, DeltaScan+ICDSC and ICDSC alone)
Time Frame
Assessed at the 14th day after ICU admission. If the patient dies during the first 14 days of the study observation period, this outcome is assessed at the date of death
Title
ICU ventilator free days
Description
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without mechanical ventilation, regardless of ventilation mode or route. High-flow nasal oxygen (HFNO) will not be regarded as ventilation. If patients are ventilated with a device provided by another institute (i.e. Centrum voor Thuisbeademing), only days spent on the ICU ventilator will be counted. Any day with <12h of mechanical ventilation will be counted as 0,5 day. More than 12h of mechanical ventilation will be counted as 1 day
Time Frame
Assessed at the 14th day after ICU admission. If the patient dies during the first 14 days of the study observation period, this outcome is assessed at the date of death
Title
ICU organ support free days
Description
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without mechanical ventilation (any modality), HFNO, renal replacement therapy (any modality), mechanical circulatory support (ECLS, IABP, Impella), intravenous inotropes (dobutamine, milrinone, enoximone, levosimendan) or vasopressors (noradrenalin > 0.25 mcg/kg/min or any dose of terlipressin / arginine vasopressin)
Time Frame
Assessed at the 14th day after ICU admission. If the patient dies during the first 14 days of the study observation period, this outcome is assessed at the date of death
Title
ICU mortality rate
Description
Defined as death occurring before ICU discharge. Outcome reported as proportion of participants who died before ICU discharge.
Time Frame
This is assessed at the date of death. In ICU survivors, it is assessed at the 90 day post-discharge follow-up
Title
ICU readmission rate
Description
Unplanned re-admission to the ICU before hospital discharge. Outcome reported as proportion of participants who were re-admitted to ICU before hospital discharge.
Time Frame
This outcome is only scored when an unplanned re-admission occurs within the first 90 days after ICU discharge.
Title
Hospital length-of-stay
Description
Outcome reported in days
Time Frame
Assessed at the 90 day post-discharge follow-up
Title
Hospital mortality rate
Description
Defined as death occurring before hospital discharge. Outcome reported as proportion of participants who died before hospital discharge.
Time Frame
This is assessed at the date of death. In survivors, it is assessed at the 90 day post-discharge follow-up
Title
90 day mortality rate
Description
Defined as death occurring within 90 days after study enrollment. Outcome reported as proportion of participants who died before 90d follow-up
Time Frame
Assessed at the 90 day post-discharge follow-up
Title
ICU Sedative Drug requirement
Description
The cumulative doses of the following sedative drugs, administered after randomisation: propofol, clonidine, dexmedetomidine, esketamine, zopiclone, benzodiazepines
Time Frame
Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
ICU opioid requirement
Description
The cumulative doses of opioids, administered after randomisation
Time Frame
Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
ICU antipsychotic drug requirement
Description
cumulative dose of the following antipsychotic drugs, administered after randomisation: haloperidol, quetiapine, other antipsychotic drugs
Time Frame
Assessed at ICU Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
ICU accidental device removal incidence and falls
Description
Defined as the number of incidents where a patient accidentally removes an indwelling catheter, tube, infusion line or drain (e.g. intravenous lines, wound drains, airway device, feeding tubes etc) or falls out of bed
Time Frame
Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
ICU incidence and duration of the use of physical restraints
Description
Defined as the frequency of application of physical restraints and the cumulative duration of restraint application during ICU admission
Time Frame
Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Title
Self-assessed quality of life
Description
Self-assessed quality of life measured with the Euroqol Quality of Life questionnaire, version EQ6D
Time Frame
Assessed one year after ICU discharge
Title
Self assessed cognitive function
Description
Self-assessed cognitive function measured with the cognitive failure questionnaire (CFQ, Merckelbach, Muris & Nijman 1996)
Time Frame
Assessed one year after ICU discharge
Title
Self assessed mood and depression symptoms
Description
Self assessed mood and depression symptoms measured with the Patient Health Questionnaire (PHQ-9)
Time Frame
Assessed one year after ICU discharge
Title
Self assessed mobility and physical functioning
Description
Self assessed mobility and physical functioning measured with the Barthel Index
Time Frame
Assessed one year after ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (18 years or above) admitted to ICU for any indication ICU length of stay anticipated to be 48h or longer from time of screening for inclusion Written informed consent by patient or representative Exclusion Criteria: More than 48 hours have elapsed since the patient was first eligible to undergo a DeltaScan measurement after ICU admission. A patient is eligible for DeltaScan measurements if they are a. able to cooperate with simple instructions AND b. are alert or mildly sedated no deeper than a Richmond Agitation and Sedation Score of -2. Admission for out-of-hospital cardiac arrest, status epilepticus, hemorrhagic or ischemic stroke, increased intracranial pressure, head trauma Recent intracranial neurosurgery (<30 days prior to inclusion) Known space-occupying lesions in the brain or skull Metal implants in brain or skull Diagnosis of dementia or Parkinson's disease Inpatient from nursing home Lithium use (<30 days prior to inclusion) Imminent death or palliative care phase Patients ánd their legal representatives both do not understand Dutch or English Patients who participated in the EARLY DELTRA trial <90 days ago
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eline Pellekoorn, RN
Phone
+31702104955
Email
e.pellekoorn@hagaziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Ottens, MD, MSc, PhD
Organizational Affiliation
HagaZiekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Rinket, RN
Phone
+31 53 487 2000
Email
researchic@mst.nl
First Name & Middle Initial & Last Name & Degree
Bert Beishuizen, MD, PhD
Phone
+31 53 487 2000
Email
b.beishuizen@mst.nl
First Name & Middle Initial & Last Name & Degree
Bert Beishuizen, MD PhD
Facility Name
HagaZiekenhuis
City
Den Haag
State/Province
Zuid Holland
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eline Pellekoorn, RN

12. IPD Sharing Statement

Plan to Share IPD
No

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The EARLY DELTA Trial

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