ICU SedationPhase 4PedruxNCT03813277
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
A Phase 4 study testing Dexmedetomidine in people with ICU Sedation, run by Orion Corporation, Orion Pharma at 1 site in Russia.
Trial summary
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- ICU Sedation
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 21 Mar 2017to 21 May 2018
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 12 to 17 years;
- Clinical need for prolonged (>24h) light to moderate sedation in patients with spontaneous or artificial ventilation
- Negative urine pregnancy test (for female patients);
- Written informed consent
Who cannot join
- Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury; any other disorder where sedation assessment is not reliable due to any neurological conditions;
- Uncompensated acute circulatory failure;
- Severe hypotension or hypertension
- Severe bradycardia or tachycardia
- A/V-conduction block II-III;
- Severe hepatic impairment
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- Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data;
- Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x halflife between drug discontinuation and the time of randomisation;
- Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
- Patients receiving sedatives for therapeutic indications (e.g. epilepsy);
- Patients allergic to dexmedetomidine and rescue medications
- Hemodialysis and peritoneal dialysis;
- Those requiring deep sedation or neuromuscular blocking agents;
- Burn injuries and other injuries requiring regular anaesthesia or surgery;
- History / family history of malignant hyperthermia;
- Patients unlikely to be weaned from the ventilator during the study;
- Patients with early-onset ventilator-associated pneumonia;
- Any investigational drug within the preceding 30 days;
- Any other reason which in the investigator's opinion would make it detrimental for the subject to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Clinical Trial to Evaluate Safety, Tolerability, and Efficacy of Dexdor for Sedation in Paediatric Patients in Intensive Care Settings. Multi-centre Trial in Russia for Marketing Registration of Dexdor.
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
Read the detailed description
Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric experiences in the literature are in the form of small studies and case reports.
Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical situations. Based on literature analysis, dexmedetomidine may be potentially used in the intensive care unit in pediatric patients who require sedation, either breath spontaneously or require mechanical ventilation.
Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to further evaluate its safety and efficacy in all age ranges.
- Conditions
- ICU Sedation
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine 100microg/ml Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients
Time spent in target sedation range (RASS score )
Measured: max 5 days
Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients
Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication)
Measured: max 5 days
Secondary outcomes (3)
Wake-up/discontinuation of sedation (if applicable)
Wake-up/discontinuation of sedation (if applicable)
Measured: max 5 days
Time to extubation.
Extubation assessment (if applicable).
Measured: max 5 days
Time to first rescue medication
Time to first rescue medication
Measured: max 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start21 Mar 2017
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU SedationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andershan Lekmahnov, Prof, Principal investigator, State Federal-Funded Educational Institution of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813277
- Sponsor's protocol ID
- 3005031
- Acronym
- Pedrux
- Status last verified
- Jan 2019
- First submitted
- 9 Nov 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Clinical Trial to Evaluate Safety, Tolerability, and Efficacy of Dexdor for Sedation in Paediatric Patients in Intensive Care Settings. Multi-centre Trial in Russia for Marketing Registration of Dexdor.
- ClinicalTrials.gov ID
- NCT03813277
- Acronym / sponsor ID
- Pedrux / 3005031
- Conditions
- ICU Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 23 Jan 2019 (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.
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
Detailed description
Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric experiences in the literature are in the form of small studies and case reports.
Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical situations. Based on literature analysis, dexmedetomidine may be potentially used in the intensive care unit in pediatric patients who require sedation, either breath spontaneously or require mechanical ventilation.
Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to further evaluate its safety and efficacy in all age ranges.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine 100microg/ml |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 12 to 17 years;
- Clinical need for prolonged (>24h) light to moderate sedation in patients with spontaneous or artificial ventilation
- Negative urine pregnancy test (for female patients);
- Written informed consent
Key exclusion criteria (19 listed)
- Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury; any other disorder where sedation assessment is not reliable due to any neurological conditions;
- Uncompensated acute circulatory failure;
- Severe hypotension or hypertension
- Severe bradycardia or tachycardia
- A/V-conduction block II-III;
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 |
|---|---|---|
| Dexmedetomidineinfusion | Drug | Dexmedetomidine |
Primary outcome
Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients
Time frame: max 5 days
Time spent in target sedation range (RASS score )
Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients
Time frame: max 5 days
Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication)
3 secondary outcomes
Wake-up/discontinuation of sedation (if applicable)
Time frame: max 5 days
Time to extubation.
Time frame: max 5 days
Time to first rescue medication
Time frame: max 5 days
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 23 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for ICU Sedation
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Ketamine Sedation in the ICU (KANINE) RCT
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Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
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Enrolling by invitationObservational study
A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients
Sedation, Analgesia Assessment
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.
Andershan Lekmahnov, Prof principal investigator
State Federal-Funded Educational Institution of
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 Dexmedetomidine in people with ICU Sedation, run by Orion Corporation, Orion Pharma at 1 site in Russia.
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 19 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 23 Jan 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 Russia. 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 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?
Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients (time frame: max 5 days). 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?
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 Jan 2019.