DeliriumPhase 2NCT03293927
Polypharmacy-related Adverse Events in Critically Ill Children
A Phase 2 study testing Fentanyl and Dexmedetomidine in people with Delirium, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Delirium
- What is being tested?
- Fentanyl and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 1 Jul 2019
- Phase
- Phase 2
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 2-<18 at the time of enrollment
- Admitted to the Duke PICU or PCICU
- Planned or anticipated mechanically ventilation for ≥2 days
- Require sedation to maintain mechanical ventilation
- No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
- Availability and willingness of the parent/legal guardian to provide written informed consent
Who cannot join
- Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- Previous participation in this study
- Planned receipt of sedatives other than fentanyl or dexmedetomidine
- Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
- Renal failure requiring renal replacement therapy
- Hepatic failure
- Support with extracorporeal membrane oxygenation
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Investigating Polypharmacy-related Adverse Events in Critically Ill Children
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.
- Conditions
- Delirium
- Being tested
- Fentanyl, Dexmedetomidine
- Keywords
- children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
The patient will receive IV fentanyl
DexmedetomidineDrug
The patient will receive IV dexemedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl + Dexmedetomidine | Experimental | Not described Receives: Drug: Fentanyl; Drug: Dexmedetomidine |
| Dexmedetomidine + Fentanyl | Experimental | Not described Receives: Drug: Fentanyl; Drug: Dexmedetomidine |
| Fentanyl only | Experimental | Not described Receives: Drug: Fentanyl |
| Dexmedetomidine only | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in delirium scores as measured by CAPD score
Measured: up to 10 days
Secondary outcomes (1)
Drug level associated with CAPD score
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start9 Apr 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Why it stopped: No participants enrolled in study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanecia Zimmerman, MD, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293927
- Sponsor's protocol ID
- Pro00084476
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Polypharmacy-related Adverse Events in Critically Ill Children
- ClinicalTrials.gov ID
- NCT03293927
- Acronym / sponsor ID
- Pro00084476
- Conditions
- Delirium
- Keywords
- children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled in study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 26 Sep 2017 (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 purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fentanyl + Dexmedetomidine | Experimental | Drug: Fentanyl, Drug: Dexmedetomidine |
| Dexmedetomidine + Fentanyl | Experimental | Drug: Fentanyl, Drug: Dexmedetomidine |
| Fentanyl only | Experimental | Drug: Fentanyl |
| Dexmedetomidine only | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ages 2-<18 at the time of enrollment
- Admitted to the Duke PICU or PCICU
- Planned or anticipated mechanically ventilation for ≥2 days
- Require sedation to maintain mechanical ventilation
- No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
Key exclusion criteria (7 listed)
- Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- Previous participation in this study
- Planned receipt of sedatives other than fentanyl or dexmedetomidine
- Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
- Renal failure requiring renal replacement therapy
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 |
|---|---|---|
| FentanylThe patient will receive IV fentanyl | Drug | Dexmedetomidine + Fentanyl, Fentanyl + Dexmedetomidine, Fentanyl only |
| DexmedetomidineThe patient will receive IV dexemedetomidine | Drug | Dexmedetomidine + Fentanyl, Dexmedetomidine only, Fentanyl + Dexmedetomidine |
Primary outcome
Change in delirium scores as measured by CAPD score
Time frame: up to 10 days
1 secondary outcome
Drug level associated with CAPD score
Time frame: up to 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Related trials for Delirium
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)
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Active, not recruiting
TaVNS for Delirium
Delirium
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
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.
Kanecia Zimmerman, MD principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fentanyl and Dexmedetomidine in people with Delirium, run by Duke University 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Jul 2019. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in delirium scores as measured by CAPD score (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.