DeliriumPhase 3NCT00300391

ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

A Phase 3 study testing haloperidol in people with Delirium, run by University of Pittsburgh.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: No sites listed yet
Study dates: Mar 2006to Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

All adult (>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require >24 hours of mechanical ventilation

Who cannot join

Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.

About this study

The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

Read the detailed description

Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.

Conditions: Delirium
Being tested: haloperidol, Saline placebo
Keywords: Delirium, Mechanical ventilation, Intensive care, Haloperidol
Medical subject headings: Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

haloperidolDrug
Also called Haldol
Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.
Saline placeboOther
control arem

Study groups in NCT00300391
Study group	Role	What they receive
haloperidol	Experimental	Once diagnosed as delirious, randomized to haloperidol 5 mg IV Receives: Drug: haloperidol
placebo	Placebo comparator	once diagnosed as delirious, received 5 mg saline placebo Receives: Other: Saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

28-day All-cause Mortality
Measured: Daily
90-day All-cause Mortality
Measured: 90 Days from enrollment in study

Secondary outcomes (2)

Duration of Mechanical Ventilation
Measured: daily
ICU Length of Stay
Measured: Daily

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Oct 2011

First posted8 Mar 2006 (estimated)
Study startMar 2006
Primary completionOct 2011
Study completionOct 2011

Why it stopped: Insufficient recruitment to meet aims.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DeliriumStudies of the same condition, open and under way.
More trials run by University of PittsburghThe 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
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00300391
Sponsor's protocol ID: 0505051
Other IDs: 1K23HL078760-01A1
Status last verified: Nov 2017
First submitted: 6 Mar 2006
Last updated: 20 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Milbrandt EB, Kersten A, Kong L, Weissfeld LA, Clermont G, Fink MP, Angus DC. Haloperidol use is associated with lower hospital mortality in mechanically ventilated patients. Crit Care Med. 2005 Jan;33(1):226-9; discussion 263-5. doi: 10.1097/01.ccm.0000150743.16005.9a.
PubMed 15644675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)

All Delirium trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
ClinicalTrials.gov ID: NCT00300391
Acronym / sponsor ID: 0505051
Conditions: Delirium
Keywords: Delirium, Mechanical ventilation, Intensive care, Haloperidol
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient recruitment to meet aims.
Enrolment: 40 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Mar 2006
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 8 Mar 2006 (estimated)
Results: Posted 20 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
haloperidol	Experimental	Drug: haloperidolOnce diagnosed as delirious, randomized to haloperidol 5 mg IV
placebo	Placebo comparator	Other: Saline placeboonce diagnosed as delirious, received 5 mg saline placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All adult (>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require >24 hours of mechanical ventilation

Key exclusion criteria (1 listed)

Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.

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: HaldolAim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.	Drug	haloperidol
Saline placebocontrol arem	Other	placebo

Primary outcome

28-day All-cause Mortality
Time frame: Daily
90-day All-cause Mortality
Time frame: 90 Days from enrollment in study

2 secondary outcomes

Duration of Mechanical Ventilation
Time frame: daily
ICU Length of Stay
Time frame: Daily

Results and safety

Results posted to the registry on 20 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Haloperidol	16	16
Placebo	14	14

Primary outcome: 28-day All-cause Mortality

Time frame: Daily. Count of participants. Unit: Participants

Measure	Delirium n = 30	Persistent Coma n = 2	No Delirium n = 7
Value	4	2	1

Population analysed: This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the "Delirium," "Persistent Coma," and "No delirium".

Primary outcome: 90-day All-cause Mortality

Time frame: 90 Days from enrollment in study. Count of participants. Unit: Participants

Measure	Delirium n = 30	Persistent Coma n = 2	No Delirium n = 7
Value	4	2	1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Haloperidol	0 of 16 (0%)	16 of 16 (100%)	1 of 16
Placebo	0 of 13 (0%)	12 of 13 (92.3%)	2 of 13

Limitations and caveats (from the sponsor): This study was pre-maturely terminated. Although sincere efforts were made to locate the relevant and accurate data, limited data could be obtained. Also, conflicting information was available with respect to participant enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15644675Milbrandt EB, Kersten A, Kong L, Weissfeld LA, Clermont G, Fink MP, Angus DC. Haloperidol use is associated with lower hospital mortality in mechanically ventilated patients. Crit Care Med. 2005 Jan;33(1):226-9; discussion 263-5. doi: 10.1097/01.ccm.0000150743.16005.9a.
Individual participant dataSharing planned: No

Related trials for Delirium

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)

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.

Eric B Milbrandt, MD, MPH principal investigator

University of Pittsburgh Medical Center

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing haloperidol in people with Delirium, run by University of Pittsburgh.

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 1 inclusion and 1 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 20 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

28-day All-cause Mortality (time frame: Daily). The study lists 2 primary outcomes in all. 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 NCT00300391, which also lists 1 linked publication.

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 20 Dec 2017.