Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU (Pedrux)

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

Study Overview

• Status: Completed
• Conditions: ICU Sedation
• Intervention / Treatment: Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • State Federal-Funded Educational Institution of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; Dexmedetomidine 100microg/ml	Drug: Dexmedetomidine; infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients	Time spent in target sedation range (RASS score )	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)	max 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wake-up/discontinuation of sedation (if applicable)	Wake-up/discontinuation of sedation (if applicable)	max 5 days
Time to extubation.	Extubation assessment (if applicable).	max 5 days
Time to first rescue medication	Time to first rescue medication	max 5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Clinical safety of dexdor infusion	max 5 days

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Andershan Lekmahnov, Prof, State Federal-Funded Educational Institution of

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): May 21, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 3005031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No