Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)

NCT03645603 | Terminated Phase 2 DMC

• 1 other identifier: EudraCT 2015-002114-80 OsSC
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional study evaluates the efficacy of dexmedetomidine during weaning from analgesic and sedative drugs in reducing the occurrence of the withdrawal syndrome in PICU. All enrolled patients will undergo the same weaning regimen one half will receive dexmedetomidine while the other will receive a placebo.

Conditions

Withdrawal Syndrome

Keywords

pediatrics; dexmedetomidine; analgesia; sedation; pediatric intensive care unit; abstinence syndrome; assessment tool

Outcome Measures

Primary Outcomes (1)

• Change in Withdrawal Assessment Tool (WAT-1) scale

  WAT-1 score recorded every 12 hours.The score ranges from 0 to 12, a score ≥3 indicates the presence of signs/symptoms of withdrawal.

  time 0 start dexmedetomidine and every 12 hours post-start dexmedetomidine for 7 days

Secondary Outcomes (3)

• Change in heart rate

  0,1, 2, 12, 24 hours post-start dexmedetomidine and then every 12 hours for 7 days

• Change in Systolic Blood Pressure

  0,1, 2, 12, 24 hours post-start dexmedetomidine and then every 12 hours for 7 days

• Change in Diastolic Blood Pressure

  0,1, 2, 12, 24 hours post-start dexmedetomidine and then every 12 hours for 7 days

Other Outcomes (2)

• Change in Opioid dose

  7 days

• Change in Sedative dose

  7 days

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 100 mcg/ml concentrate solution. Continuous iv infusion. Start dose 0.4 mcg/kg/h, increases by 0.2 mcg/kg/h until 0.8 mcg/kg/h (half dose for neonates). If withdrawal symptoms appear the dose can be increased to a maximum of 1.4 mcg/Kg/h.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

saline solution for IV infusion. The administration of infusion will follow the experimental drug.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

intravenous infusion

Also known as: Dexdor, Precedex

Dexmedetomidine

Placebo DRUG

intravenous infusion of physiological saline solution to mimic dexmedetomidine infusion

Also known as: physiological saline solution

Placebo

Eligibility Criteria

• Age: 7 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Continuous analgesic and sedative endovenous treatment for at least 5 days
• Invasive or non-invasive mechanical ventilation
• Clinical conditions that allow by clinical judgment the start of analgosedation weaning
• Post-natal age ≥ 7 days and PMA beyond the 37 weeks
• Written informed consent obtained

You may not qualify if:

• Hemodynamic instability
• Cardiac bundle-branch block of 2 or 3 degree
• Hypersensitivity to the alpha-agonists
• Persistent fever of unknown origin or sensitivity to malignant hyperthermia
• Use of alpha-agonist (clonidine or dexmedetomidine) in the last 30 days

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Azienda Ospedaliera di Padova: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

PICU Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

Related Publications (3)

• Amigoni A, Mondardini MC, Vittadello I, Zaglia F, Rossetti E, Vitale F, Ferrario S, Savron F, Coffaro G, Brugnaro L, Amato R, Wolfler A, Franck LS; Network of Paediatric Intensive Care Unit Study Group (TIPNet). Withdrawal Assessment Tool-1 Monitoring in PICU: A Multicenter Study on Iatrogenic Withdrawal Syndrome. Pediatr Crit Care Med. 2017 Feb;18(2):e86-e91. doi: 10.1097/PCC.0000000000001054.

  PMID: 28157809 RESULT

• Mondardini MC, Daverio M, Caramelli F, Conti G, Zaggia C, Lazzarini R, Muscheri L, Azzolina D, Gregori D, Sperotto F, Amigoni A. Dexmedetomidine for prevention of opioid/benzodiazepine withdrawal syndrome in pediatric intensive care unit: Interim analysis of a randomized controlled trial. Pharmacotherapy. 2022 Feb;42(2):145-153. doi: 10.1002/phar.2654. Epub 2021 Dec 21.

  PMID: 34882826 DERIVED

• Mondardini MC, Sperotto F, Daverio M, Caramelli F, Gregori D, Caligiuri MF, Vitale F, Cecini MT, Piastra M, Mancino A, Pettenazzo A, Conti G, Amigoni A. Efficacy and safety of dexmedetomidine for prevention of withdrawal syndrome in the pediatric intensive care unit: protocol for an adaptive, multicenter, randomized, double-blind, placebo-controlled, non-profit clinical trial. Trials. 2019 Dec 11;20(1):710. doi: 10.1186/s13063-019-3793-6.

  PMID: 31829274 DERIVED

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Maria C. Mondardini, MD

  Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola-Malpighi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 24, 2018
• Study Start: August 30, 2018
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)