DeliriumPhase 4REDUCENCT01785290
pRophylactic halopEriDol Use for Delirium in iCu patiEnts With a High Risk for Delirium
A Phase 4 study testing Haloperidol 1 mg/q8h and Haloperidol 2 mg/q8h in people with Delirium, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol in patients with a high risk to develop delirium, defined by an expected ICU length of stay of >1 day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Haloperidol 1 mg/q8h and Haloperidol 2 mg/q8h
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Mar 2017
- Phase
- Phase 4
- 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
- age ≥ 18
- expected length of ICU stay of over one day
Who cannot join
- history of epilepsy, Parkinson's disease, hypokinetic rigid syndrome, dementia or alcohol withdrawal syndrome
- patients admitted to the ICU for neurological reasons (including post-resuscitation patients)
- patients treated with other anti-psychotics
- prolonged QTc-time (>500msec) or history of serious ventricular arrhythmia (in last 12 months)
- pregnancy/breast feeding
- delirious before ICU admission
Show all 13Show fewer
- serious auditory or visual disorders
- ICU-stay ≤1 day
- unable to understand Dutch
- severely mentally disabled
- serious receptive aphasia
- moribund and not expected to survive 2 days
- known allergy to haloperidol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Haloperidol Use for Delirium in ICU Patients; a Randomized Placebo-controlled Double-blind Multicentre Trial
The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol in patients with a high risk to develop delirium, defined by an expected ICU length of stay of >1 day. The investigators hypothesized that haloperidol prophylaxis in patients with a high risk for delirium reduces 28-day mortality, delirium and delirium related outcome.
Two different dosages of haloperidol are used in this study to compare with placebo. A dosage of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in a three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the potential beneficial effects of haloperidol to the a priori risk to develop delirium, the PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable the investigators to determine the preventive efficacy of haloperidol in patient groups based on their risk to develop delirium.
Read the detailed description
In this study high risk patients will be included. Based on historical data the investigators know that the median predicted delirium risk is 35% in patients with an expected stay on the ICU of over one day. This is considered a high risk to develop delirium.
To assess patients for delirium using the Confusion Assessment Method (CAM)-ICU is part of daily clinical practice in all participating centres. In this study, high risk patients will receive three times a day a study drug of which two groups receive a low dose of haloperidol (1mg or 2mg) and a third arm will receive placebo.
This drug is worldwide the first choice of drug to treat delirious patients. When delirium is diagnosed, patients are treated according to delirium protocol, using a higher dosage than in the prophylactic treatment period as described in the study protocol. It is recognized that early treatment of delirium has beneficial effects compared with delayed treatment, and there is also some evidence that delirium prevention in ICU patients has beneficial effects, but the design of these previous studies was not optimal.
Potential side-effects of haloperidol include, extrapyramidal symptoms, drowsiness, agitation, and ventricular arrhythmias. The latter are extremely rare (only case-reports are published) and related to a higher dosage of haloperidol. With the dosage that will be used in the present study no relevant side-effects are anticipated. Nevertheless, and given the preventive nature of this study, extra attention is being paid on recognition of possible side-effects of haloperidol in the protocol. Importantly, in three recent prophylactic haloperidol studies no relevant side-effects, and in particular no ventricular arrhythmias, were reported using a similar low dosage of haloperidol as described in the present protocol.
During the study several inter-rater reliability checks (delirium experts versus ICU nurses) concerning the CAM_ICU assessments will be performed. Also medical and nursing files will be checked to secure the quality of the delirium diagnose.
The study will be monitored (all sites), randomly included patient data will be checked on delirium diagnose and endpoints of the study. All data will be collected by Electronic CRF. A check of completeness on all data is build-in.
All variables are defined using a data dictionary (using the NICE data dictionary) supplemented with definitions of PREDELIRIC-model predictors, delirium diagnosis (at least one positive CAM-ICU assessment), and delirium duration.
Sample size calculation is based on the effect on number of days of survival in 28-days mortality derived from the evaluation study using low dosage of prophylactic haloperidol. If the true hazard ratio of control patients relative to intervention patients is 0.85, taken into account an accrual time of 90 days with 28 days of follow-up, the investigators will need to study 647 patients per intervention group and 647 control patients to be able to reject the null hypothesis that the experimental and control survival curves are equal with probability (power) 0.80. The Type I error probability associated with this test of this null hypothesis is 0.05. Taken into account a drop out of 10% the investigators will include 715 patients per group; in total 2145 patients. The investigators assume that the effect on number of days of survival in 28-days mortality will be comparable between the two intervention groups. The Cox-regression analysis group will have three levels (placebo, 1 mg and 2 mg haloperidol three times daily).
A Data Safety Monitoring Board (DSMB)will monitor the safety of the study including interim analyses on safety/futility after 175-350 and 500 patients and safety and superiority after 1000 patients. Followed by a final analysis after 2145 patients.
Only for the interim analysis after 500 and 1000 patients adjusting for covariates (age, gender, delirium prediction score and sepsis) will be performed to determine the effect on 28-day survival
This multicenter study will be performed in:
- Radboud University Nijmegen Medical Centre
- University Medical Centre Utrecht
- Medical Centre Leeuwarden (stopped January 2014)
- Onze Lieve Vrouwen Gasthuis, Amsterdam (stopped March 2015)
- Isala Clinic, Zwolle (stopped June 2014)
- Canisius Wilhelmina Ziekenhuis, Nijmegen
- Medisch Spectrum Twente, Enschede
- Gelre Hospital, Apeldoorn
- Atrium Medical Centre, Heerlen
- Jeroen Bosch Hospital, Den-Bosch
- Atrium Medical Centre, Heerlen
- Medical Centre Haaglanden (Westeinde and Antoniushove), Den-Haag
- Bronovo Hospital, Den-Haag
- St. Jansdal Hospital, Harderwijk
- Maxima Medical Centre, Veldhoven
- University Medical Centre, Groningen
- Amphia Hospital, Breda
- VieCuri Hospital, Venlo
- Scheper Hospital, Emmen (stopped August 2016)
- Diakonessenhuis Hospital, Utrecht
- Haga Hospital, Den-Haag
After the 4th interim analysis the DSMB advised to drop on study arm due to effectivity and efficiency reasons. Since July 2015 the study has been continued with two study arms and the included numbers of patients is adjusted to 1800 patients.
- Conditions
- Delirium
- Being tested
- Haloperidol 1 mg/q8h, Haloperidol 2 mg/q8h, Placebo
- Keywords
- Delirium, Survival, Side-effects, QoL
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol 1 mg/q8hDrug
Also called Haldol
Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients:
- aged ≥ 80 years
- weight ≤ 50 kg
- liver failure
Patients with an adjusted dosage of study drug remain allocated to their original group.
In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group.
Haloperidol 2 mg/q8hDrug
Also called Haldol
Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients:
- aged ≥ 80 years
- weight ≤ 50 kg
- liver failure
Patients with an adjusted dosage of study drug remain allocated to their original group.
In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group.
PlaceboDrug
Also called Sodium Chloride 0.9%
Sodium Chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol 1mg/q8h | Experimental | Prophylactic haloperidol of 1 mg/q8h i.v. Receives: Drug: Haloperidol 1 mg/q8h |
| Haloperidol 2mg/q8h | Experimental | Prophylactic haloperidol 2mg/q8h i.v. Receives: Drug: Haloperidol 2 mg/q8h |
| Sodium chloride 0.9% | Placebo comparator | Placebo (Sodium chloride 0.9%) three times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Number of days of survival in 28-days after inclusion.
Measured: 28-day
Secondary outcomes (6)
Delirium incidence during ICU stay
The onset of delirium during ICU admission
Measured: up to 28 days
Number of delirium free days
Number of delirium and coma-free days in 28 days
Measured: 28 days
Delirium related outcome during ICU stay
Time to successful extubation, incidence of re-intubation, incidence of ICU readmission, and incidence of unplanned removal of tubes and catheters during period of 28-days after inclusion of study, use of physical restraints
Measured: up to 28 days
Determining efficacy in different risk groups
Determine the preventive efficacy of haloperidol in different patient groups based on the a priori risk to develop delirium: In patients with a predicted risk up to 50%, 50-70%, 70-90%, above 90% the effect of haloperidol will be determined
Measured: up to 28 days
Side effects of haloperidol prophylaxis during prophylactic treatment
Evaluating the incidence of known side effects of haloperidol during the prophylactic treatment period
Measured: up to 28 days
All cause mortality
Number of days of survival in 90-days after inclusion, survival analysis stratifying for delirium incidence will be performed
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Radboud University 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Mark van den Boogaard, PhD, Principal investigator, Radboud University Nijmegen Medical Centre, Dept of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785290
- Sponsor's protocol ID
- Delirium_Haldol-prophy
- Other IDs
- 2012-004012-66, 2012/424
- Acronym
- REDUCE
- Status last verified
- Dec 2015
- First submitted
- 31 Jan 2013
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: on request available
Publications
Duprey MS, van den Boogaard M, van der Hoeven JG, Pickkers P, Briesacher BA, Saczynski JS, Griffith JL, Devlin JW. Association between incident delirium and 28- and 90-day mortality in critically ill adults: a secondary analysis. Crit Care. 2020 Apr 20;24(1):161. doi: 10.1186/s13054-020-02879-6.
PubMed 32312288Heesakkers H, Devlin JW, Slooter AJC, van den Boogaard M. Association between delirium prediction scores and days spent with delirium. J Crit Care. 2020 Aug;58:6-9. doi: 10.1016/j.jcrc.2020.03.008. Epub 2020 Mar 25.
PubMed 32247156van den Boogaard M, Slooter AJC, Bruggemann RJM, Schoonhoven L, Beishuizen A, Vermeijden JW, Pretorius D, de Koning J, Simons KS, Dennesen PJW, Van der Voort PHJ, Houterman S, van der Hoeven JG, Pickkers P; REDUCE Study Investigators; van der Woude MCE, Besselink A, Hofstra LS, Spronk PE, van den Bergh W, Donker DW, Fuchs M, Karakus A, Koeman M, van Duijnhoven M, Hannink G. Effect of Haloperidol on Survival Among Critically Ill Adults With a High Risk of Delirium: The REDUCE Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):680-690. doi: 10.1001/jama.2018.0160.
PubMed 29466591van den Boogaard M, Slooter AJ, Bruggemann RJ, Schoonhoven L, Kuiper MA, van der Voort PH, Hoogendoorn ME, Beishuizen A, Schouten JA, Spronk PE, Houterman S, van der Hoeven JG, Pickkers P. Prevention of ICU delirium and delirium-related outcome with haloperidol: a study protocol for a multicenter randomized controlled trial. Trials. 2013 Nov 21;14:400. doi: 10.1186/1745-6215-14-400.
PubMed 24261644
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Haloperidol Use for Delirium in ICU Patients; a Randomized Placebo-controlled Double-blind Multicentre Trial
- ClinicalTrials.gov ID
- NCT01785290
- Acronym / sponsor ID
- REDUCE / Delirium_Haldol-prophy
- Conditions
- Delirium
- Keywords
- Delirium, Survival, Side-effects, QoL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Feb 2013 (estimated)
- 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 aim of this study is to determine the effects of a low dosage of prophylactic haloperidol in patients with a high risk to develop delirium, defined by an expected ICU length of stay of >1 day. The investigators hypothesized that haloperidol prophylaxis in patients with a high risk for delirium reduces 28-day mortality, delirium and delirium related outcome.
Two different dosages of haloperidol are used in this study to compare with placebo. A dosage of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in a three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the potential beneficial effects of haloperidol to the a priori risk to develop delirium, the PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable the investigators to determine the preventive efficacy of haloperidol in patient groups based on their risk to develop delirium.
Detailed description
In this study high risk patients will be included. Based on historical data the investigators know that the median predicted delirium risk is 35% in patients with an expected stay on the ICU of over one day. This is considered a high risk to develop delirium.
To assess patients for delirium using the Confusion Assessment Method (CAM)-ICU is part of daily clinical practice in all participating centres. In this study, high risk patients will receive three times a day a study drug of which two groups receive a low dose of haloperidol (1mg or 2mg) and a third arm will receive placebo.
This drug is worldwide the first choice of drug to treat delirious patients. When delirium is diagnosed, patients are treated according to delirium protocol, using a higher dosage than in the prophylactic treatment period as described in the study protocol. It is recognized that early treatment of delirium has beneficial effects compared with delayed treatment, and there is also some evidence that delirium prevention in ICU patients has beneficial effects, but the design of these previous studies was not optimal.
Potential side-effects of haloperidol include, extrapyramidal symptoms, drowsiness, agitation, and ventricular arrhythmias. The latter are extremely rare (only case-reports are published) and related to a higher dosage of haloperidol. With the dosage that will be used in the present study no relevant side-effects are anticipated. Nevertheless, and given the preventive nature of this study, extra attention is being paid on recognition of possible side-effects of haloperidol in the protocol. Importantly, in three recent prophylactic haloperidol studies no relevant side-effects, and in particular no ventricular arrhythmias, were reported using a similar low dosage of haloperidol as described in the present protocol.
During the study several inter-rater reliability checks (delirium experts versus ICU nurses) concerning the CAM_ICU assessments will be performed. Also medical and nursing files will be checked to secure the quality of the delirium diagnose.
The study will be monitored (all sites), randomly included patient data will be checked on delirium diagnose and endpoints of the study. All data will be collected by Electronic CRF. A check of completeness on all data is build-in.
All variables are defined using a data dictionary (using the NICE data dictionary) supplemented with definitions of PREDELIRIC-model predictors, delirium diagnosis (at least one positive CAM-ICU assessment), and delirium duration.
Sample size calculation is based on the effect on number of days of survival in 28-days mortality derived from the evaluation study using low dosage of prophylactic haloperidol. If the true hazard ratio of control patients relative to intervention patients is 0.85, taken into account an accrual time of 90 days with 28 days of follow-up, the investigators will need to study 647 patients per intervention group and 647 control patients to be able to reject the null hypothesis that the experimental and control survival curves are equal with probability (power) 0.80. The Type I error probability associated with this test of this null hypothesis is 0.05. Taken into account a drop out of 10% the investigators will include 715 patients per group; in total 2145 patients. The investigators assume that the effect on number of days of survival in 28-days mortality will be comparable between the two intervention groups. The Cox-regression analysis group will have three levels (placebo, 1 mg and 2 mg haloperidol three times daily).
A Data Safety Monitoring Board (DSMB)will monitor the safety of the study including interim analyses on safety/futility after 175-350 and 500 patients and safety and superiority after 1000 patients. Followed by a final analysis after 2145 patients.
Only for the interim analysis after 500 and 1000 patients adjusting for covariates (age, gender, delirium prediction score and sepsis) will be performed to determine the effect on 28-day survival
This multicenter study will be performed in:
- Radboud University Nijmegen Medical Centre
- University Medical Centre Utrecht
- Medical Centre Leeuwarden (stopped January 2014)
- Onze Lieve Vrouwen Gasthuis, Amsterdam (stopped March 2015)
- Isala Clinic, Zwolle (stopped June 2014)
- Canisius Wilhelmina Ziekenhuis, Nijmegen
- Medisch Spectrum Twente, Enschede
- Gelre Hospital, Apeldoorn
- Atrium Medical Centre, Heerlen
- Jeroen Bosch Hospital, Den-Bosch
- Atrium Medical Centre, Heerlen
- Medical Centre Haaglanden (Westeinde and Antoniushove), Den-Haag
- Bronovo Hospital, Den-Haag
- St. Jansdal Hospital, Harderwijk
- Maxima Medical Centre, Veldhoven
- University Medical Centre, Groningen
- Amphia Hospital, Breda
- VieCuri Hospital, Venlo
- Scheper Hospital, Emmen (stopped August 2016)
- Diakonessenhuis Hospital, Utrecht
- Haga Hospital, Den-Haag
After the 4th interim analysis the DSMB advised to drop on study arm due to effectivity and efficiency reasons. Since July 2015 the study has been continued with two study arms and the included numbers of patients is adjusted to 1800 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Haloperidol 1mg/q8h | Experimental | Drug: Haloperidol 1 mg/q8hProphylactic haloperidol of 1 mg/q8h i.v. |
| Haloperidol 2mg/q8h | Experimental | Drug: Haloperidol 2 mg/q8hProphylactic haloperidol 2mg/q8h i.v. |
| Sodium chloride 0.9% | Placebo comparator | Drug: PlaceboPlacebo (Sodium chloride 0.9%) three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18
- expected length of ICU stay of over one day
Key exclusion criteria (13 listed)
- history of epilepsy, Parkinson's disease, hypokinetic rigid syndrome, dementia or alcohol withdrawal syndrome
- patients admitted to the ICU for neurological reasons (including post-resuscitation patients)
- patients treated with other anti-psychotics
- prolonged QTc-time (>500msec) or history of serious ventricular arrhythmia (in last 12 months)
- pregnancy/breast feeding
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 |
|---|---|---|
| Haloperidol 1 mg/q8hAlso: HaldolPatients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients: * aged ≥ 80 years * weight ≤ 50 kg * liver failure Patients with an adjusted dosage of study drug remain allocated to their original group. In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group. | Drug | Haloperidol 1mg/q8h |
| Haloperidol 2 mg/q8hAlso: HaldolPatients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients: * aged ≥ 80 years * weight ≤ 50 kg * liver failure Patients with an adjusted dosage of study drug remain allocated to their original group. In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group. | Drug | Haloperidol 2mg/q8h |
| PlaceboAlso: Sodium Chloride 0.9%Sodium Chloride 0.9% | Drug | Sodium chloride 0.9% |
Primary outcome
All cause mortality
Time frame: 28-day
Number of days of survival in 28-days after inclusion.
6 secondary outcomes
Delirium incidence during ICU stay
Time frame: up to 28 days
Number of delirium free days
Time frame: 28 days
Delirium related outcome during ICU stay
Time frame: up to 28 days
Determining efficacy in different risk groups
Time frame: up to 28 days
Side effects of haloperidol prophylaxis during prophylactic treatment
Time frame: up to 28 days
All cause mortality
Time frame: 90 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 32312288Duprey MS, van den Boogaard M, van der Hoeven JG, Pickkers P, Briesacher BA, Saczynski JS, Griffith JL, Devlin JW. Association between incident delirium and 28- and 90-day mortality in critically ill adults: a secondary analysis. Crit Care. 2020 Apr 20;24(1):161. doi: 10.1186/s13054-020-02879-6.
- Derived from this study: PubMed 32247156Heesakkers H, Devlin JW, Slooter AJC, van den Boogaard M. Association between delirium prediction scores and days spent with delirium. J Crit Care. 2020 Aug;58:6-9. doi: 10.1016/j.jcrc.2020.03.008. Epub 2020 Mar 25.
- Derived from this study: PubMed 29466591van den Boogaard M, Slooter AJC, Bruggemann RJM, Schoonhoven L, Beishuizen A, Vermeijden JW, Pretorius D, de Koning J, Simons KS, Dennesen PJW, Van der Voort PHJ, Houterman S, van der Hoeven JG, Pickkers P; REDUCE Study Investigators; van der Woude MCE, Besselink A, Hofstra LS, Spronk PE, van den Bergh W, Donker DW, Fuchs M, Karakus A, Koeman M, van Duijnhoven M, Hannink G. Effect of Haloperidol on Survival Among Critically Ill Adults With a High Risk of Delirium: The REDUCE Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):680-690. doi: 10.1001/jama.2018.0160.
- Derived from this study: PubMed 24261644van den Boogaard M, Slooter AJ, Bruggemann RJ, Schoonhoven L, Kuiper MA, van der Voort PH, Hoogendoorn ME, Beishuizen A, Schouten JA, Spronk PE, Houterman S, van der Hoeven JG, Pickkers P. Prevention of ICU delirium and delirium-related outcome with haloperidol: a study protocol for a multicenter randomized controlled trial. Trials. 2013 Nov 21;14:400. doi: 10.1186/1745-6215-14-400.
- Individual participant dataSharing planned: Yes. on request available
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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.
Mark van den Boogaard, PhD principal investigator
Radboud University Nijmegen Medical Centre, Dept of Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol 1 mg/q8h and Haloperidol 2 mg/q8h in people with Delirium, run by Radboud University Medical Center at 1 site 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All cause mortality (time frame: 28-day). 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 NCT01785290, which also lists 4 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 12 Nov 2020.