Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)
NCT ID: NCT03645603
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
2018-08-30
2020-01-18
Brief Summary
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Detailed Description
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Withdrawal symptoms are due to central nervous system excitement, gastrointestinal disturbance, and sympathetic system activation. The incidence of withdrawal syndrome is variable between 17 and 57% a recent study reported an incidence of 64.6% of WS in Italian PICUs. The prevention strategies are addressed to the restriction of drug exposure and to the gradual tapering of infusion. However, these strategies have weak evidence of effectiveness. In this study, the investigators hypothesize that dexmedetomidine may be useful and effective during the weaning of analgosedation drugs in PICU, in preventing the withdrawal syndrome. The primary aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the occurrence of the WS. Secondary aims are to evaluate the dexmedetomidine safety during the weaning, the effective dose range, and the efficacy in reducing the duration of the weaning, of the mechanical ventilation, and of the length of PICU stay. Efficacy will be compared among pediatric age groups, gender, race, Pediatric Index of Mortality (PIM3) score, and length of the analgosedation treatment.
Patients admitted to the PICU that meets the inclusion criteria, will be randomly assigned to one of the two treatment groups: treatment A (dexmedetomidine) or treatment B (placebo).
Twenty-four hours before the start of the weaning an intravenous infusion of dexmedetomidine/placebo will start. After 24 hours of dexmedetomidine infusion, the weaning regimen will begin following the subsequent indications: 10% reduction of the dose every 12 hours. The withdrawal assessment tool version 1 (WAT-1) is the selected scale to evaluate the occurrence of the WS. Patients with a score of WAT-1 \<3 continue the weaning regimen. Patients with a score ≥3 increase the dose of dexmedetomidine/placebo until the next WAT-1 score control and temporarily stop the planned 10% dose reduction. If the next WAT-1 score decreased by at least 1 point from the previous score, the weaning program restarted (10% reduction) without further changes in the dose of dexmedetomidine/placebo until the subsequent score. The 'acute withdrawal crisis' will be treated with a rescue dose of the opioid and/or benzodiazepine in use repeatable until resolution of the crisis. Once analgesics and sedatives weaning is complete, dexmedetomidine will gradually discontinue. Five days after discharge from PICU, a follow-up visit will be performed.
The sample size estimate is 80 participants for each of the two groups for a total of 160 patients recruited within a period of two years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dexmedetomidine
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.
Dexmedetomidine
intravenous infusion
Placebo
saline solution for IV infusion. The administration of infusion will follow the experimental drug.
Placebo
intravenous infusion of physiological saline solution to mimic dexmedetomidine infusion
Interventions
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Dexmedetomidine
intravenous infusion
Placebo
intravenous infusion of physiological saline solution to mimic dexmedetomidine infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
7 Days
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera di Padova
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Maria Cristina Mondardini
Principal Investigator
Principal Investigators
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Maria C. Mondardini, MD
Role: STUDY_CHAIR
Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola-Malpighi
Locations
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PICU Policlinico S.Orsola-Malpighi
Bologna, , Italy
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EudraCT 2015-002114-80 OsSC
Identifier Type: -
Identifier Source: org_study_id