ICU Sedation Clinical Trial
— PedruxOfficial 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.
NCT number | NCT03813277 |
Other study ID # | 3005031 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 21, 2017 |
Est. completion date | May 21, 2018 |
Verified date | January 2019 |
Source | Orion Corporation, Orion Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | May 21, 2018 |
Est. primary completion date | May 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
Inclusion Criteria: 1. Age from 12 to 17 years; 2. Clinical need for prolonged (>24h) light to moderate sedation in patients with spontaneous or artificial ventilation 3. Negative urine pregnancy test (for female patients); 4. Written informed consent Exclusion Criteria: 1. 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; 2. Uncompensated acute circulatory failure; 3. Severe hypotension or hypertension 4. Severe bradycardia or tachycardia 5. A/V-conduction block II-III; 6. Severe hepatic impairment 7. Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data; 8. Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x halflife between drug discontinuation and the time of randomisation; 9. Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis 10. Patients receiving sedatives for therapeutic indications (e.g. epilepsy); 11. Patients allergic to dexmedetomidine and rescue medications 12. Hemodialysis and peritoneal dialysis; 13. Those requiring deep sedation or neuromuscular blocking agents; 14. Burn injuries and other injuries requiring regular anaesthesia or surgery; 15. History / family history of malignant hyperthermia; 16. Patients unlikely to be weaned from the ventilator during the study; 17. Patients with early-onset ventilator-associated pneumonia; 18. Any investigational drug within the preceding 30 days; 19. Any other reason which in the investigator's opinion would make it detrimental for the subject to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | State Federal-Funded Educational Institution of | Moscow |
Lead Sponsor | Collaborator |
---|---|
Orion Corporation, Orion Pharma |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety and tolerability | Clinical safety of dexdor infusion | max 5 days | |
Primary | Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients | Time spent in target sedation range (RASS score ) | max 5 days | |
Primary | Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients | Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication) | max 5 days | |
Secondary | Wake-up/discontinuation of sedation (if applicable) | Wake-up/discontinuation of sedation (if applicable) | max 5 days | |
Secondary | Time to extubation. | Extubation assessment (if applicable). | max 5 days | |
Secondary | Time to first rescue medication | Time to first rescue medication | max 5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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