Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU

NCT03813277 | Completed Phase 4

• 1 other identifier: 3005031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ICU Sedation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Wake-up/discontinuation of sedation (if applicable)

  max 5 days

• Time to extubation.

  max 5 days

• Time to first rescue medication

  max 5 days

Other Outcomes (1)

• Safety and tolerability

  max 5 days

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 100microg/ml

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

infusion

Dexmedetomidine

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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• Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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;

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

State Federal-Funded Educational Institution of

Moscow, 117997, Russia

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andershan Lekmahnov, Prof

  State Federal-Funded Educational Institution of

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: January 23, 2019
• Study Start: March 21, 2017
• Primary Completion: May 21, 2018
• Study Completion: May 21, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)