Hypoactive DeliriumPhase 4FLYPNCT02899156
Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure
A Phase 4 study testing Flumazenil in people with Hypoactive Delirium, run by University of California, Davis at 1 site in United States.
Trial summary
Delirium within the intensive care unit (ICU) is associated with poor outcomes such as increased mortality, ICU and hospital length of stay (LOS), and time on mechanical ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoactive Delirium
- What is being tested?
- Flumazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 16 Apr 2019
- Phase
- Phase 4
- 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
- critically ill adults
- RASS score of -3 to 0 after receiving benzodiazepine therapy
- CAM-ICU positive
- no benzodiazepine therapy within the previous 12 hours
Who cannot join
- contraindications to flumazenil including hypersensitivity
- receipt of benzodiazepines for control of potentially life-threatening conditions (e.g., control of intracranial pressure or status epilepticus)
- active seizure disorder or on current anti-convulsant therapy for history of seizure disorder. Seizures secondary to alcohol withdrawal will NOT be excluded.
- history of traumatic brain injury complicated by seizures
- acute episode (within prior 30 days) of severe traumatic brain injury
- history of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage) complicated by seizures
Show all 17Show fewer
- acute episode (within prior 14 days) of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage)
- brain tumor complicated by seizure
- history of anoxic brain injury
- third-degree burn with total body surface area (TBSA) burn greater than 20%
- chronic benzodiazepine (clonazepam:lorazepam:diazepam approximately 4:8:40 mg per day) for 7 consecutive days with no taper
- chronic delirium that is attributable to other causes
- anticipated to transfer to lower level of care within 24 hours
- admitted for polysubstance overdose as determined by initial drug toxicity screening
- recent exposure (prior 7 days) to pro-convulsant medications (identified via medication list, medication reconciliation performed by PI/pharmacy medication reconciliation team, or urine drug screening)
- children, incarcerated individuals, and pregnant women
- unable to provide consent and the legally authorized representative is unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Effect of Flumazenil on Hypoactive Delirium in the ICU: A Double-Blind, Placebo-Controlled Pilot Study
Delirium within the intensive care unit (ICU) is associated with poor outcomes such as increased mortality, ICU and hospital length of stay (LOS), and time on mechanical ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing duration of delirium and subsequent complications.
This is a single-center randomized, double-blind, placebo-controlled study of critically ill adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that flumazenil continuous infusion may reverse hypoactive delirium associated with BZD exposure and thereby reduce duration of delirium and ICU LOS.
Read the detailed description
Benzodiazepines are commonly used for discomfort, anxiety, agitation, and alcohol withdrawal syndrome (AWS) in the ICU. End organ dysfunction and extended exposure can increase the risk of complications associated with BZDs, which include increased ICU LOS, time on mechanical ventilation, and mortality.
Flumazenil as a 1, 4-imidazobenzodiazepine is a competitive antagonist for the benzodiazepine binding site with weak intrinsic or partial agonistic activity on the GABA receptor. Multiple studies have confirmed the safety and effectiveness of flumazenil for the reversal of sedation. Pilot studies have demonstrated safe reversal of over-sedation and statistically significant improvements in patient cooperation and time to extubation. The current standard for suspected BZD-associated hypoactive delirium is cessation of benzodiazepine administration and supportive care.
The role of continuous infusion flumazenil for rapid and sustained reversal of hypoactive delirium in the ICU has not been evaluated prospectively and therefore remains poorly defined.
- Conditions
- Hypoactive Delirium
- Being tested
- Flumazenil, Placebo
- Keywords
- delirium, flumazenil, hypoactive delirium, benzodiazepine, benzodiazepine antagonist, critical care
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
Also called Romazicon
PlaceboDrug
0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Flumazenil Infusion | Active comparator | The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr. Receives: Drug: Flumazenil |
| Placebo Infusion | Placebo comparator | The placebo continuous infusion is started at an initial dose of 0.1 mg/hr (2 ml/hr)., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Delirium-free Days
Defined by the number of days in the 14-day period after randomization that the patient was alive and not delirious (i.e. CAM-ICU negative). Zero delirium-free days will be observed for patients that die within the 14-day period.
Measured: up to 14 days after randomization
Secondary outcomes (6)
Number of Participants With Delirium Resolution
defined by the proportion of patients who were delirium free at 14 days after randomization
Measured: up to 14 days after randomization
Intensive Care Unit Length of Stay
length of time that the patient was admitted to an intensive care unit service during the hospital stay
Measured: duration of admission to the intensive care unit
Number of Mechanical Ventilator Free Days
number of days within the first 28 days after enrollment that the patient was free from needing mechanical ventilation
Measured: up to 28 days after randomization
Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion
number of times that a RASS score of + 2 to +4 occurred that did not resolve with decreasing study infusion
Measured: up to 72 hours after the start of the infusion
Average Duration of Study Infusion
average duration of time patient was randomized to each infusion up to 72 hours
Measured: up to 72 hours after the start of the infusion
Average Maximum Rate of Study Infusion
average maximum rate (ml/hr) during the 72 hours after study infusion
Measured: up to 72 hours after the start of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startMar 2016
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Why it stopped: A planned interim analysis led to the trial being stopped early based on the observed size effect and power analysis.
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 (31)Papers the sponsor has linked to this study.
- Other trials for Hypoactive DeliriumStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kendra J Schomer, PharmD, Principal investigator, University of California, DavisJeremiah J Duby, PharmD, BCPS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899156
- Sponsor's protocol ID
- 837421
- Acronym
- FLYP
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2016
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pandharipande P, Shintani A, Peterson J, Pun BT, Wilkinson GR, Dittus RS, Bernard GR, Ely EW. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006 Jan;104(1):21-6. doi: 10.1097/00000542-200601000-00005.
PubMed 16394685Zaal IJ, Devlin JW, Hazelbag M, Klein Klouwenberg PM, van der Kooi AW, Ong DS, Cremer OL, Groenwold RH, Slooter AJ. Benzodiazepine-associated delirium in critically ill adults. Intensive Care Med. 2015 Dec;41(12):2130-7. doi: 10.1007/s00134-015-4063-z. Epub 2015 Sep 24.
PubMed 26404392Shehabi Y, Bellomo R, Reade MC, Bailey M, Bass F, Howe B, McArthur C, Seppelt IM, Webb S, Weisbrodt L; Sedation Practice in Intensive Care Evaluation (SPICE) Study Investigators; ANZICS Clinical Trials Group. Early intensive care sedation predicts long-term mortality in ventilated critically ill patients. Am J Respir Crit Care Med. 2012 Oct 15;186(8):724-31. doi: 10.1164/rccm.201203-0522OC. Epub 2012 Aug 2.
PubMed 22859526Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.
PubMed 24423152Brogden RN, Goa KL. Flumazenil. A reappraisal of its pharmacological properties and therapeutic efficacy as a benzodiazepine antagonist. Drugs. 1991 Dec;42(6):1061-89. doi: 10.2165/00003495-199142060-00010.
PubMed 1724638Breheny FX. Reversal of midazolam sedation with flumazenil. Crit Care Med. 1992 Jun;20(6):736-9. doi: 10.1097/00003246-199206000-00006.
PubMed 1597024Pepperman ML. Double-blind study of the reversal of midazolam-induced sedation in the intensive care unit with flumazenil (Ro 15-1788): effect on weaning from ventilation. Anaesth Intensive Care. 1990 Feb;18(1):38-44. doi: 10.1177/0310057X9001800107.
PubMed 2110788Penninga EI, Graudal N, Ladekarl MB, Jurgens G. Adverse Events Associated with Flumazenil Treatment for the Management of Suspected Benzodiazepine Intoxication--A Systematic Review with Meta-Analyses of Randomised Trials. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):37-44. doi: 10.1111/bcpt.12434. Epub 2015 Jul 28.
PubMed 26096314Kreshak AA, Cantrell FL, Clark RF, Tomaszewski CA. A poison center's ten-year experience with flumazenil administration to acutely poisoned adults. J Emerg Med. 2012 Oct;43(4):677-82. doi: 10.1016/j.jemermed.2012.01.059. Epub 2012 Jul 4.
PubMed 22766408Moore PW, Donovan JW, Burkhart KK, Waskin JA, Hieger MA, Adkins AR, Wert Y, Haggerty DA, Rasimas JJ. Safety and efficacy of flumazenil for reversal of iatrogenic benzodiazepine-associated delirium toxicity during treatment of alcohol withdrawal, a retrospective review at one center. J Med Toxicol. 2014 Jun;10(2):126-32. doi: 10.1007/s13181-014-0391-6.
PubMed 24619543Bodenham A, Park GR. Reversal of prolonged sedation using flumazenil in critically ill patients. Anaesthesia. 1989 Jul;44(7):603-5. doi: 10.1111/j.1365-2044.1989.tb11455.x.
PubMed 2505628Spivey WH, Roberts JR, Derlet RW. A clinical trial of escalating doses of flumazenil for reversal of suspected benzodiazepine overdose in the emergency department. Ann Emerg Med. 1993 Dec;22(12):1813-21. doi: 10.1016/s0196-0644(05)80407-x.
PubMed 8239101Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
PubMed 26041151Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
PubMed 11797025
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flumazenil on Hypoactive Delirium in the ICU: A Double-Blind, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02899156
- Acronym / sponsor ID
- FLYP / 837421
- Conditions
- Hypoactive Delirium
- Keywords
- delirium, flumazenil, hypoactive delirium, benzodiazepine, benzodiazepine antagonist, critical care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A planned interim analysis led to the trial being stopped early based on the observed size effect and power analysis.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 23 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delirium within the intensive care unit (ICU) is associated with poor outcomes such as increased mortality, ICU and hospital length of stay (LOS), and time on mechanical ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing duration of delirium and subsequent complications.
This is a single-center randomized, double-blind, placebo-controlled study of critically ill adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that flumazenil continuous infusion may reverse hypoactive delirium associated with BZD exposure and thereby reduce duration of delirium and ICU LOS.
Detailed description
Benzodiazepines are commonly used for discomfort, anxiety, agitation, and alcohol withdrawal syndrome (AWS) in the ICU. End organ dysfunction and extended exposure can increase the risk of complications associated with BZDs, which include increased ICU LOS, time on mechanical ventilation, and mortality.
Flumazenil as a 1, 4-imidazobenzodiazepine is a competitive antagonist for the benzodiazepine binding site with weak intrinsic or partial agonistic activity on the GABA receptor. Multiple studies have confirmed the safety and effectiveness of flumazenil for the reversal of sedation. Pilot studies have demonstrated safe reversal of over-sedation and statistically significant improvements in patient cooperation and time to extubation. The current standard for suspected BZD-associated hypoactive delirium is cessation of benzodiazepine administration and supportive care.
The role of continuous infusion flumazenil for rapid and sustained reversal of hypoactive delirium in the ICU has not been evaluated prospectively and therefore remains poorly defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flumazenil Infusion | Active comparator | Drug: FlumazenilThe flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr. |
| Placebo Infusion | Placebo comparator | Drug: PlaceboThe placebo continuous infusion is started at an initial dose of 0.1 mg/hr (2 ml/hr)., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- critically ill adults
- RASS score of -3 to 0 after receiving benzodiazepine therapy
- CAM-ICU positive
- no benzodiazepine therapy within the previous 12 hours
Key exclusion criteria (17 listed)
- contraindications to flumazenil including hypersensitivity
- receipt of benzodiazepines for control of potentially life-threatening conditions (e.g., control of intracranial pressure or status epilepticus)
- active seizure disorder or on current anti-convulsant therapy for history of seizure disorder. Seizures secondary to alcohol withdrawal will NOT be excluded.
- history of traumatic brain injury complicated by seizures
- acute episode (within prior 30 days) of severe traumatic brain injury
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 |
|---|---|---|
| FlumazenilAlso: Romazicon | Drug | Flumazenil Infusion |
| Placebo0.9% normal saline | Drug | Placebo Infusion |
Primary outcome
Number of Delirium-free Days
Time frame: up to 14 days after randomization
Defined by the number of days in the 14-day period after randomization that the patient was alive and not delirious (i.e. CAM-ICU negative). Zero delirium-free days will be observed for patients that die within the 14-day period.
6 secondary outcomes
Number of Participants With Delirium Resolution
Time frame: up to 14 days after randomization
Intensive Care Unit Length of Stay
Time frame: duration of admission to the intensive care unit
Number of Mechanical Ventilator Free Days
Time frame: up to 28 days after randomization
Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion
Time frame: up to 72 hours after the start of the infusion
Average Duration of Study Infusion
Time frame: up to 72 hours after the start of the infusion
Average Maximum Rate of Study Infusion
Time frame: up to 72 hours after the start of the infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16394685Pandharipande P, Shintani A, Peterson J, Pun BT, Wilkinson GR, Dittus RS, Bernard GR, Ely EW. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006 Jan;104(1):21-6. doi: 10.1097/00000542-200601000-00005.
- Background: PubMed 26404392Zaal IJ, Devlin JW, Hazelbag M, Klein Klouwenberg PM, van der Kooi AW, Ong DS, Cremer OL, Groenwold RH, Slooter AJ. Benzodiazepine-associated delirium in critically ill adults. Intensive Care Med. 2015 Dec;41(12):2130-7. doi: 10.1007/s00134-015-4063-z. Epub 2015 Sep 24.
- Background: PubMed 22859526Shehabi Y, Bellomo R, Reade MC, Bailey M, Bass F, Howe B, McArthur C, Seppelt IM, Webb S, Weisbrodt L; Sedation Practice in Intensive Care Evaluation (SPICE) Study Investigators; ANZICS Clinical Trials Group. Early intensive care sedation predicts long-term mortality in ventilated critically ill patients. Am J Respir Crit Care Med. 2012 Oct 15;186(8):724-31. doi: 10.1164/rccm.201203-0522OC. Epub 2012 Aug 2.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 24423152Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.
- Background: PubMed 1724638Brogden RN, Goa KL. Flumazenil. A reappraisal of its pharmacological properties and therapeutic efficacy as a benzodiazepine antagonist. Drugs. 1991 Dec;42(6):1061-89. doi: 10.2165/00003495-199142060-00010.
- Background: PubMed 1597024Breheny FX. Reversal of midazolam sedation with flumazenil. Crit Care Med. 1992 Jun;20(6):736-9. doi: 10.1097/00003246-199206000-00006.
- Background: PubMed 2110788Pepperman ML. Double-blind study of the reversal of midazolam-induced sedation in the intensive care unit with flumazenil (Ro 15-1788): effect on weaning from ventilation. Anaesth Intensive Care. 1990 Feb;18(1):38-44. doi: 10.1177/0310057X9001800107.
- Background: PubMed 26096314Penninga EI, Graudal N, Ladekarl MB, Jurgens G. Adverse Events Associated with Flumazenil Treatment for the Management of Suspected Benzodiazepine Intoxication--A Systematic Review with Meta-Analyses of Randomised Trials. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):37-44. doi: 10.1111/bcpt.12434. Epub 2015 Jul 28.
- Background: PubMed 22766408Kreshak AA, Cantrell FL, Clark RF, Tomaszewski CA. A poison center's ten-year experience with flumazenil administration to acutely poisoned adults. J Emerg Med. 2012 Oct;43(4):677-82. doi: 10.1016/j.jemermed.2012.01.059. Epub 2012 Jul 4.
- Background: PubMed 24619543Moore PW, Donovan JW, Burkhart KK, Waskin JA, Hieger MA, Adkins AR, Wert Y, Haggerty DA, Rasimas JJ. Safety and efficacy of flumazenil for reversal of iatrogenic benzodiazepine-associated delirium toxicity during treatment of alcohol withdrawal, a retrospective review at one center. J Med Toxicol. 2014 Jun;10(2):126-32. doi: 10.1007/s13181-014-0391-6.
- Background: PubMed 2505628Bodenham A, Park GR. Reversal of prolonged sedation using flumazenil in critically ill patients. Anaesthesia. 1989 Jul;44(7):603-5. doi: 10.1111/j.1365-2044.1989.tb11455.x.
- Individual participant dataSharing planned: No
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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.
Kendra J Schomer, PharmD principal investigator
University of California, Davis
Jeremiah J Duby, PharmD, BCPS principal investigator
University of California, Davis
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 Flumazenil in people with Hypoactive Delirium, run by University of California, Davis at 1 site in United States.
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 4 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 23 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2020). 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?
Number of Delirium-free Days (time frame: up to 14 days after randomization). 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 NCT02899156, which also lists 31 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 23 Jul 2020.