DeliriumPhase 3EuRIDICENCT03628391
Haloperidol for Delirium in Adult Critically Ill Patients
A Phase 3 study testing Haloperidol in people with Delirium and Critical Illness, run by Erasmus Medical Center at 8 sites in Netherlands.
Trial summary
The EuRIDICE trial will study whether haloperidol as a first line treatment for ICU delirium reduces delirium duration (and severity). Adverse outcomes typically associated with delirium will also be studied and include long term cognition, functional outcome and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Critical Illness, Intensive Care Psychosis
- What is being tested?
- Haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 8 sitesNetherlands
- Study dates
- 22 Feb 2018to 23 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Delirium, as assessed with the Intensive Care Delirium Screening Checklist - ICDSC: ≥4 or Confusion Assessment Method for the ICU - CAM-ICU: positive). NB Delirium can occur in the course of ICU admission or be present at admission.
- Written Informed Consent is obtained from patient or legal representative
- Complies with inclusion criteria but NOT exclusion criteria for eligibility:
- Eligibility
- Age ≥ 18 years
- Admitted to ICU.
Who cannot join
- Admitted to ICU with a neurological diagnosis (such as acute stroke, traumatic brain injury, intracranial malignancy, anoxic coma). Previous non-acute stroke or other previous neurological condition without cognitive deterioration is not an exclusion criterion.
- Pregnancy (to be excluded by pregnancy test in women of child baring age)
- History of ventricular arrhythmia including "torsade de pointes" (TdP)
- Known allergy to haloperidol
- History of dementia or an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4
- History of malignant neuroleptic syndrome or parkinsonism (either Parkinson's disease or another hypokinetic rigid syndrome)
Show all 17Show fewer
- Schizophrenia or other psychotic disorder
- Inability to conduct valid delirium screening assessment (e.g. coma, deaf, blind) or inability to speak Dutch
- The patient is expected to die within 24 hours, or is expected to leave the ICU within 24 hours after evaluation (may be reassessed daily)
- Prolonged QT-interval (QTc > 500ms)
- (recent) "torsade de pointes" (TdP)
- (recent) malignant neuroleptic syndrome or parkinsonism
- Evidence of acute alcohol (or substance) withdrawal requiring pharmacological intervention (e.g. benzodiazepines or alfa-2 agonist) to treat
- IQCODE not assessed
- The patient is expected to die within 24 hours, or is expected to leave the ICU within 24 hours.
- No (previously) signed informed consent by patient or representative
- Current participation in another intervention trial that is evaluating a medication, device or behavioural intervention
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch
IJsselland Hospital
Capelle aan den IJssel
Albert Schweitzer Hospital
Dordrecht
Radboudumc
Nijmegen
ErasmusMC
Rotterdam
Franciscus Gasthuis (Hospital)
Rotterdam
Ikazia Hospital
Rotterdam
Maasstad Hospital
Rotterdam
About this study
Official title: Efficacy of Haloperidol to Decrease the Burden of Delirium in Adult Critically Ill Patients (EuRIDICE): a Prospective Randomised Multi-center Double-blind Placebo-controlled Clinical Trial
The EuRIDICE trial will study whether haloperidol as a first line treatment for ICU delirium reduces delirium duration (and severity). Adverse outcomes typically associated with delirium will also be studied and include long term cognition, functional outcome and quality of life. Further, patient and family experiences and cost-effectiveness will be assessed. Finally, safety concerns associated with the use of haloperidol in this vulnerable population will be studied.
Read the detailed description
BACKGROUND. Although widely used, the efficacy and safety of haloperidol for delirium in critically ill adults remain unclear. A randomised controlled trial is warranted to study the effect of haloperidol on delirium or coma, long-term outcomes, safety concerns, and cost-effectiveness.
SUMMARY.
The investigators will perform a multi-center, randomised, double-blind, placebo-controlled clinical trial to evaluate the use of haloperidol for delirium treatment in 742 critically ill adults with delirium. Days spent without delirium- or coma in the first 14 days after randomisation is the primary outcome. Study drug will be initiated at 2.5mg IV q8h and increased after 24 hours to 5mg IV q8h if delirium persists. Study drug dose will be tapered when delirium has resolved during 24 hours. All patients will be managed with a standardized pain, agitation and delirium protocol. Standard operating procedures for agitation (analgesia titration, alpha2 agonists) and hallucination management (atypical antipsychotics) will be implemented to accommodate possible imbalances of these symptoms in both treatment arms. Open-label haloperidol administration is discouraged during the trial. The sample size provides a power of 90% to detect statistically significant results (p<.05) and a true treatment difference of one day for the primary outcome between trial arms.
This trial is expected to answer the clinically relevant question whether haloperidol still deserves a place in ICU delirium management. The primary outcome (delirium- and coma-free days) will be related to the secondary outcomes cognitive dysfunction, functional and psychological outcomes and patient- and family experiences. An extensive cost-effectiveness analysis will be done. Mortality at one year and safety concerns of haloperidol (QTc prolongation on EKG and rigidity) will be assessed as secondary endpoints. In conclusion, this large multicentre trial will assess efficacy and safety of haloperidol for ICU delirium.
- Conditions
- Delirium, Critical Illness, Intensive Care Psychosis, Cognitive Impairment, Cognitive Decline
- Being tested
- Haloperidol, Placebo
- Keywords
- delirium, intensive care unit, critical illness, cognitive impairment
- Medical subject headings
- Delirium, Critical Illness, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called not any
haloperidol for ICU delirium, titrated on validated screening tool-based diagnosis
PlaceboDrug
placebo for ICU delirium, titrated on validated screening tool-based diagnosis
| Study group | Role | What they receive |
|---|---|---|
| haloperidol | Active comparator | study drug will be titrated based on delirium, diagnosed with a validated screening instrument (CAM-ICU or ICDSC), starting with 2.5mg IV q8h and titrated to a maximum of 5mg IV q8h.
Agitation and hallucinations will be managed according to a pre-specified protocol in both treatment arms. First the study drug will be increased when agitation or delirium remain present. Further options include mainly the use of alfa-2 agonists (agitation) or atypical antipsychotic drugs (hallucinations). Receives: Drug: Haloperidol |
| placebo | Placebo comparator | study drug will be titrated based on delirium, diagnosed with a validated screening instrument (CAM-ICU or ICDSC), starting with 2.5mg IV q8h and titrated to a maximum of 5mg IV q8h.
Agitation and hallucinations will be managed according to a pre-specified protocol in both treatment arms. First the study drug will be increased when agitation or delirium remain present. Further options include mainly the use of alfa-2 agonists (agitation) or atypical antipsychotic drugs (hallucinations). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium- and coma-free days
days without brain dysfunction (=delirium OR coma) while at the ICU
Measured: within the first 14 days after randomisation
Secondary outcomes (17)
Cognitive deterioration: Global cognitive functioning
Global cognitive functioning as assessed with the Montreal Cognitive Assessment (MOCA). Total score will be reported, with a range of 0-30 (higher values representing better cognitive functioning).
Measured: 3 and 12 months
Cognitive deterioration: Verbal learning and memory
Auditory-verbal learning and memory will be assessed with the Rey Auditory Verbal Learning Test. Three subscores will be reported: total correct words in 5 trials (range: 0 -75), total correct words after delay (range: 0-15) and total correct words at recognition (range: 0-30).
Measured: 3 and 12 months
Cognitive deterioration: Semantic fluency
Semantic fluency will be tested with the Semantic Category Fluency Test. The amount of animals given within a time of 60 seconds will represent the score.
Measured: 3 and 12 months
Cognitive deterioration: Working memory
Working memory will be assessed using the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Subscales will be reported for both digit span under forward and backward recall conditions. In addition, a total score will be reported, which equals the sum of both separate digit spans.
Measured: 3 and 12 months
Cognitive deterioration: Cognitive flexibility
Cognitive flexibility, one of the executive funcions, will be assessed with the Trialmaking tests A and B. The total amount of seconds needed to finish each test will be reported, with less seconds needed representing better cognitive flexibility.
Measured: 3 and 12 months
Cognitive deterioration: Word retrieval
Word retrieval is tested with the Boston Naming Test (30-item version). The total score (range: 0-30) represents the amount of correct answered drawings.
Measured: 3 and 12 months
Anxiety and depression
Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). Two subscales will be reported, one for anxiety symptoms (range: 0-21) and one for depression symptoms (range: 0-21). Higher values represent a worse outcome. A subscore >8 indicates anxiety or depression, respectively.
Measured: 3 and 12 months
Functional outcome
Health-related quality of life will be assessed with the Short Form-35 (SF-36). Nine subscales will be reported on a 0 - 100 scale: physical functioning, role functioning - physical, bodily pain, general health, vitality, social functioning, role functioning - emotional, mental health and reported health transition. Higher values represent a better health-related quality of life.
Measured: 3 and 12 months
mortality
mortality
Measured: 28 days and 1 year
length of stay at ICU
length of stay at ICU (days)
Measured: days of ICU stay (time in days from ICU admission until ICU discharge). Assessed up to a maximum of 12 months after randomisation (end of follow-up period).
Adverse drug associated events: prolonged QTc by EKG
prolonged QTc by EKG (ms)
Measured: while on study drug treatment during study period at ICU (up to 14 days after randomisation)
Adverse drug associated events: muscle rigidity and other associated movements disorders
muscle rigidity and other associated movements disorders [measured with the Simpson Angus Scale]
Measured: while on study drug treatment during study period at ICU (up to 14 days after randomisation)
Adverse drug associated events: ventricular arrhythmia's
ventricular arrhythmia's including torsade de pointes
Measured: during study period at ICU (up to 14 days after randomisation)
Patients' memories related to their ICU stay
Patients' memories for their ICU stay will be evaluated with the ICU Memory Tool (ICU-MT). Subscores will be reported for factual memories (range: 0-11), delusion memories (range: 0-6) and memories of feelings (range: 0-4).
Measured: at discharge from hospital (up to a maximum of 12 months after randomisation = end of follow-up period) and 3 months after randomisation
Patients' and family-members' experiences related to delirium
Delirium recall and distress related to the delirium episode will be assessed with the Delirium Experience Questionnaire (DEQ). Scores will represent whether patients remember their delirium episode. In addition, a score representing delirium-related distress levels (range: 0-4, with higher values representing more distress) will be reported for both patients and family-members.
Measured: at discharge from hospital (up to a maximum of 12 months after randomisation = end of follow-up period) and 3 months after randomisation
Caregiver Strain
The strain experienced by family-members or relatives will be assessed with the Caregiver Strain Index. A total score (range: 0-13) will be reported, with higher values representing higher experienced strain.
Measured: at 3 months after randomisation
Posttraumatic stress syndrome
Posttraumatic stress symptoms in patients and families will be assessed with the Impact of Event Scale - Revised (IES-R). A mean total IES-R score will be reported (range: 0-4), with posttraumatic stress disorder defined as a mean IES-R score ≥ 1.6. In addition, subscores will be reported for intrusion, avoidance and hyperarousal (range: 0-4).
Measured: at 3 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start22 Feb 2018
- Primary completion3 Feb 2020
- Study completion23 Jan 2021
Why it stopped: The study was stopped because of futility of being able to reach a one-day difference between treatment groups in the primary outcome of DCFD in the intended sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled double-blind placebo controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Mathieu van der Jagt, Erasmus Medical Center
- Investigators
- Mathieu van der Jagt, MD PhD, Principal investigator, Erasmus University Medical Center Rotterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628391
- Sponsor's protocol ID
- MEC-2017-115/NL62689.078.17
- Acronym
- EuRIDICE
- Status last verified
- May 2022
- First submitted
- 9 Oct 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be retrieved after contacting the principal investigator
Publications
Smit L, Slooter AJC, Devlin JW, Trogrlic Z, Hunfeld NGM, Osse RJ, Ponssen HH, Brouwers AJBW, Schoonderbeek JF, Simons KS, van den Boogaard M, Lens JA, Boer DP, Gommers DAMPJ, Rietdijk WJR, van der Jagt M; EuRIDICE study group. Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: the EuRIDICE randomized clinical trial. Crit Care. 2023 Oct 30;27(1):413. doi: 10.1186/s13054-023-04692-3.
PubMed 37904241Smit L, Trogrlic Z, Devlin JW, Osse RJ, Ponssen HH, Slooter AJC, Hunfeld NGM, Rietdijk WJR, Gommers D, van der Jagt M; EuRIDICE study group. Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands. BMJ Open. 2020 Sep 23;10(9):e036735. doi: 10.1136/bmjopen-2019-036735.
PubMed 32967873
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Haloperidol to Decrease the Burden of Delirium in Adult Critically Ill Patients (EuRIDICE): a Prospective Randomised Multi-center Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03628391
- Acronym / sponsor ID
- EuRIDICE / MEC-2017-115/NL62689.078.17
- Conditions
- Delirium, Critical Illness, Intensive Care Psychosis, Cognitive Impairment, Cognitive Decline
- Keywords
- delirium, intensive care unit, critical illness, cognitive impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because of futility of being able to reach a one-day difference between treatment groups in the primary outcome of DCFD in the intended sample size.
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EuRIDICE trial will study whether haloperidol as a first line treatment for ICU delirium reduces delirium duration (and severity). Adverse outcomes typically associated with delirium will also be studied and include long term cognition, functional outcome and quality of life. Further, patient and family experiences and cost-effectiveness will be assessed. Finally, safety concerns associated with the use of haloperidol in this vulnerable population will be studied.
Detailed description
BACKGROUND. Although widely used, the efficacy and safety of haloperidol for delirium in critically ill adults remain unclear. A randomised controlled trial is warranted to study the effect of haloperidol on delirium or coma, long-term outcomes, safety concerns, and cost-effectiveness.
SUMMARY.
The investigators will perform a multi-center, randomised, double-blind, placebo-controlled clinical trial to evaluate the use of haloperidol for delirium treatment in 742 critically ill adults with delirium. Days spent without delirium- or coma in the first 14 days after randomisation is the primary outcome. Study drug will be initiated at 2.5mg IV q8h and increased after 24 hours to 5mg IV q8h if delirium persists. Study drug dose will be tapered when delirium has resolved during 24 hours. All patients will be managed with a standardized pain, agitation and delirium protocol. Standard operating procedures for agitation (analgesia titration, alpha2 agonists) and hallucination management (atypical antipsychotics) will be implemented to accommodate possible imbalances of these symptoms in both treatment arms. Open-label haloperidol administration is discouraged during the trial. The sample size provides a power of 90% to detect statistically significant results (p<.05) and a true treatment difference of one day for the primary outcome between trial arms.
This trial is expected to answer the clinically relevant question whether haloperidol still deserves a place in ICU delirium management. The primary outcome (delirium- and coma-free days) will be related to the secondary outcomes cognitive dysfunction, functional and psychological outcomes and patient- and family experiences. An extensive cost-effectiveness analysis will be done. Mortality at one year and safety concerns of haloperidol (QTc prolongation on EKG and rigidity) will be assessed as secondary endpoints. In conclusion, this large multicentre trial will assess efficacy and safety of haloperidol for ICU delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled double-blind placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| haloperidol | Active comparator | Drug: Haloperidolstudy drug will be titrated based on delirium, diagnosed with a validated screening instrument (CAM-ICU or ICDSC), starting with 2.5mg IV q8h and titrated to a maximum of 5mg IV q8h. Agitation and hallucinations will be managed according to a pre-specified protocol in both treatment arms. First the study drug will be increased when agitation or delirium remain present. Further options include mainly the use of alfa-2 agonists (agitation) or atypical antipsychotic drugs (hallucinations). |
| placebo | Placebo comparator | Drug: Placebostudy drug will be titrated based on delirium, diagnosed with a validated screening instrument (CAM-ICU or ICDSC), starting with 2.5mg IV q8h and titrated to a maximum of 5mg IV q8h. Agitation and hallucinations will be managed according to a pre-specified protocol in both treatment arms. First the study drug will be increased when agitation or delirium remain present. Further options include mainly the use of alfa-2 agonists (agitation) or atypical antipsychotic drugs (hallucinations). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Delirium, as assessed with the Intensive Care Delirium Screening Checklist - ICDSC: ≥4 or Confusion Assessment Method for the ICU - CAM-ICU: positive). NB Delirium can occur in the course of ICU admission or be present at admission.
- Written Informed Consent is obtained from patient or legal representative
- Complies with inclusion criteria but NOT exclusion criteria for eligibility:
- Eligibility
- Age ≥ 18 years
Key exclusion criteria (17 listed)
- Admitted to ICU with a neurological diagnosis (such as acute stroke, traumatic brain injury, intracranial malignancy, anoxic coma). Previous non-acute stroke or other previous neurological condition without cognitive deterioration is not an exclusion criterion.
- Pregnancy (to be excluded by pregnancy test in women of child baring age)
- History of ventricular arrhythmia including "torsade de pointes" (TdP)
- Known allergy to haloperidol
- History of dementia or an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolAlso: not anyhaloperidol for ICU delirium, titrated on validated screening tool-based diagnosis | Drug | haloperidol |
| Placeboplacebo for ICU delirium, titrated on validated screening tool-based diagnosis | Drug | placebo |
Primary outcome
delirium- and coma-free days
Time frame: within the first 14 days after randomisation
days without brain dysfunction (=delirium OR coma) while at the ICU
17 secondary outcomes
Cognitive deterioration: Global cognitive functioning
Time frame: 3 and 12 months
Cognitive deterioration: Verbal learning and memory
Time frame: 3 and 12 months
Cognitive deterioration: Semantic fluency
Time frame: 3 and 12 months
Cognitive deterioration: Working memory
Time frame: 3 and 12 months
Cognitive deterioration: Cognitive flexibility
Time frame: 3 and 12 months
Cognitive deterioration: Word retrieval
Time frame: 3 and 12 months
Anxiety and depression
Time frame: 3 and 12 months
Functional outcome
Time frame: 3 and 12 months
mortality
Time frame: 28 days and 1 year
length of stay at ICU
Time frame: days of ICU stay (time in days from ICU admission until ICU discharge). Assessed up to a maximum of 12 months after randomisation (end of follow-up period).
Adverse drug associated events: prolonged QTc by EKG
Time frame: while on study drug treatment during study period at ICU (up to 14 days after randomisation)
Adverse drug associated events: muscle rigidity and other associated movements disorders
Time frame: while on study drug treatment during study period at ICU (up to 14 days after randomisation)
Adverse drug associated events: ventricular arrhythmia's
Time frame: during study period at ICU (up to 14 days after randomisation)
Patients' memories related to their ICU stay
Time frame: at discharge from hospital (up to a maximum of 12 months after randomisation = end of follow-up period) and 3 months after randomisation
Patients' and family-members' experiences related to delirium
Time frame: at discharge from hospital (up to a maximum of 12 months after randomisation = end of follow-up period) and 3 months after randomisation
Caregiver Strain
Time frame: at 3 months after randomisation
Posttraumatic stress syndrome
Time frame: at 3 months after randomisation
Results and safety
The study was stopped early (reason given: The study was stopped because of futility of being able to reach a one-day difference between treatment groups in the primary outcome of DCFD in the intended sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 37904241Smit L, Slooter AJC, Devlin JW, Trogrlic Z, Hunfeld NGM, Osse RJ, Ponssen HH, Brouwers AJBW, Schoonderbeek JF, Simons KS, van den Boogaard M, Lens JA, Boer DP, Gommers DAMPJ, Rietdijk WJR, van der Jagt M; EuRIDICE study group. Efficacy of haloperidol to decrease the burden of delirium in adult critically ill patients: the EuRIDICE randomized clinical trial. Crit Care. 2023 Oct 30;27(1):413. doi: 10.1186/s13054-023-04692-3.
- Derived from this study: PubMed 32967873Smit L, Trogrlic Z, Devlin JW, Osse RJ, Ponssen HH, Slooter AJC, Hunfeld NGM, Rietdijk WJR, Gommers D, van der Jagt M; EuRIDICE study group. Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands. BMJ Open. 2020 Sep 23;10(9):e036735. doi: 10.1136/bmjopen-2019-036735.
- Individual participant dataSharing planned: Undecided. Can be retrieved after contacting the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu van der Jagt, MD PhD principal investigator
Erasmus University Medical Center Rotterdam, The Netherlands
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haloperidol in people with Delirium and Critical Illness, run by Erasmus Medical Center at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped because of futility of being able to reach a one-day difference between treatment groups in the primary outcome of DCFD in the intended sample size.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium- and coma-free days (time frame: within the first 14 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.