A Phase 3 interventional study of Dexmedetomidine and Sodium chloride 0.9% in ICU Delirium, sponsored by University Hospital, Brest. Completed at 9 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment
Among 78 studies testing dexmedetomidine in Delirium — 16 open to participants now, 18 under way, 4 of them phase 3. Dexmedetomidine · Delirium.
Among the 78 studies testing dexmedetomidine in Delirium, this one is the 17th largest by enrollment, is one of 8 that started in 2019, is one of 11 in phase 3, and was the 39th registered.
933 studies on the registry are indexed under Delirium; 189 are open to participants now.
Browse Delirium studies →16 of the 78 studies testing dexmedetomidine in Delirium are open now, in 6 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 60+
Bruyere Research Institute · Sites in Canada
Ages 18+
Tanta University · Sites in Egypt
Ages 21+
Tanta University · Sites in Egypt
Ages 65+
Beijing Tiantan Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 127 Delirium studies recruiting now, 99 (78%) set no upper age limit and 8 (6%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 12 · Phase 4 35
First in 2004; this study’s year is marked. 8 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 348 is above the median of 112 across 550 interventional studies indexed under Delirium.
Median enrollment 98 across the 78 interventional studies. Of the 36 that completed or were terminated, 8 (22%) have results posted.
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4 of 78 have an industry lead sponsor. The 10 most frequent:
University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
University Hospital, Brest has 3 studies filed under Delirium — fewer than ten, so there is no comparison to draw.
3 of the studies testing dexmedetomidine in Delirium that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06192615Phase 3Massachusetts General HospitalMinimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) | 2027-10-31 |
| NCT04669457University of Massachusetts, WorcesterPediatric Delirium | 2027-04-05 |
| NCT07781462Alexandria UniversityIntravenous Infusion of Low Dose Ketamine Versus Dexmedetomedine for Delirium Treatment in Acute Heart Failure | 2027-09 |
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Among the 78 studies testing dexmedetomidine in Delirium, from their registry updates:
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We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.
Delirium occurs in about 25% of patients after cardiac surgery. It is an independent factor of poor outcome and recovery after ICU stay as it is associated with mortality and impaired mental function one year after its onset. It is associated with increased public health costs during the hospital stay and after.
The use of Dexmedetomidine as sedative medication is more and more described. It is well established that it can lower delirium onset comparatively to Midazolam or Propofol. It is also useful in agitated delirium as a complementary medication to reduce delirium duration. A study published by Su et al in 2016 assessed the efficacy of Dexmedetomidine in prevention of post-surgical delirium for patients older than 65 years after non cardiac surgery. Patients were mainly admitted in the ICU after abdominal surgery for malignant tumor. Dexmedetomidine was used at very low dose to promote sleep during ICU stay. In this study the onset of delirium was significantly lowered by one half for the first week after surgery. However, this study only focused on older patients and non-cardiac surgery population with short mechanical ventilation duration, short ICU stay and low incidence of complications.
We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events. In the study by Su and al low dose Dexmedetomidine did not induce adverse events such as bradycardia or hypotension, conversely safety outcomes showed that Dexmedetomidine use was associated with fewer tachycardia and hypoxaemia. Moreover, data shows that Dexmedetomidine is likely to play a cardio protective role in the same way as Clonidine. Those findings are encouraging for its use after cardiac surgery.
Delirium will be assessed by the Confusion Assessment Method for the ICU (CAM ICU) and the primary endpoint of the study is the occurrence of delirium in the first 7 days following surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.
Drug: Dexmedetomidine
Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.
Drug: Sodium chloride 0.9%
Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.
Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.
Delirium
Occurrence of delirium diagnosed by the Confusion Assessment Method (CAM ICU) at any time in the first seven days after surgery
Time frame: 7 days
agitation with be assessed using the Richmond agitation and sedation score
Score Term Description * 4 Combative Overtly combative or violent; immediate danger to staff * 3 Very agitated Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff * 2 Agitated Frequent nonpurposeful movement or patient-ventilator dyssynchrony * 1 Restless Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm Spontaneously pays attention to caregiver * 1 Drowsy Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice * 2 Light sedation Briefly (less than 10 seconds) awakens with eye contact to voice * 3 Moderate sedation Any movement (but no eye contact) to voice * 4 Deep sedation No response to voice, but any movement to physical stimulation * 5 Unarousable No response to voice or physical stimulation
Time frame: 7 days
length of ICU stay
Lenght of patient's ICU stay
Time frame: 28 days
length of hospital stay
Length of Patient's hospital stay
Time frame: 28 days
quality of life 3 months after surgery with the The Short Form (36) Health Survey score
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The original SF-36 came out from the Medical Outcome Study, MOS, done by the RAND Corporation. Since then a group of researchers from the original study released a commercial version of SF-36 while the original SF-36 is available in public domain license free from RAND.
Time frame: 90 days
cognitive capacity 3 months after surgery evaluated with the Cognitive Failures Questionnnaire (CFQ)
The Cognitive Failures Questionnaire is a self-report scale that taps failures in everyday actions, perception and attention, and memory over the last month. It consists of 25 items that are scored on a 5-point scale (0=never; 4=very often). Illustrative items are 'Do you fail to notice signposts on the road?' and 'Do you forget where you put something like a newspaper or a book?' Scores are summed to obtain a total CFQ score varying from 0 to 100, with higher scores indicating more self-reported cognitive failures.
Time frame: 90 days
agitation related adverse events onset and number
-self-extubation
Time frame: 7 days
agitation related adverse events onset and number
-catheter or medical devices removal (drains, urinary catheter, arterial and central venous catheters, externenal pacemaker)
Time frame: 7 days
agitation related adverse events onset and number
-fall of bed
Time frame: 7 days
agitation related adverse events onset and number
-getaway
Time frame: 7 days
agitation related adverse events onset and number
-contention removal
Time frame: 7 days
agitation related adverse events onset and number
-aggressive acts
Time frame: 7 days
Self-assessment of sleep quality
Assessment by a numerical scale from 0 to 10 and the Leeds Sleep questionnaire
Time frame: 7 days
Intra hospital mortality and Mortality at 3 months of surgery
Time frame: 3 months
Cognitive capacity
Cognitive capacity assessed by Cognitive Failures Questionnaire (CFQ) at 3 months of surgery
Time frame: 3 months
Post-traumatic stress disorder
Post-traumatic stress disorder assessed by the PCL-5 questionnaire at 3 months of surgery
Time frame: 3 months
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available beginning five years and ending fifteen years following the final study report completion
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Ran from Jan 2019 to primary completion in Jun 2021, 29 months.
Of 27 phase 3 interventional studies under Delirium, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 59. This study's 29 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine