Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2019-07-18
2020-11-06
Brief Summary
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This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.
Detailed Description
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An interim analysis is planned for this trial.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Fen. SOC+saline placebo (bolus+infusion)
Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)
Fentanyl
Fentanyl standard of care
Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)
Fentanyl
Fentanyl standard of care
Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)
Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)
Fentanyl
Fentanyl standard of care
Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)
Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)
Fentanyl
Fentanyl standard of care
Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
Interventions
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Fentanyl
Fentanyl standard of care
Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)
Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)
Dexmedetomidine
Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
Eligibility Criteria
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Inclusion Criteria
2. If \< 6 months postnatal age, gestational age ≥ 35 weeks.
3. Admitted to an intensive care unit.
4. Planned or anticipated mechanically ventilation for ≥2 days.
5. Require sedation to maintain mechanical ventilation per clinical judgment.
6. No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment.
7. Availability and willingness of the parent/legal guardian to provide written informed consent.
Exclusion Criteria
2. Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) \>3.
3. Planned receipt of sedatives other than fentanyl or dexmedetomidine.
4. Anticipated receipt of neuromuscular blockade for \>48 consecutive hours during the study period.
5. Receipt of fentanyl or dexmedetomidine via continuous infusion for \>12 hours in the 24 hours prior to enrollment.
6. Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.
7. Chronic use of or recent overdose of serotonergic agents (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, cyclic antidepressants)
8. Known pregnancy
9. Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2x the upper limit of normal for age
10. Known or impending renal failure defined as: anuria \> or equal to 12 hours prior to enrollment or requiring renal replacement therapy
11. High risk children, define as: a. known heart block b. known bradyarrythmia including clinically significant bradycardia (defined as requiring chronotropic agents or cardiac pacing to treat)
12. Receipt of mechanical ventilation during an admission for cardiac surgery
Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Johns Hopkins University
OTHER
Intermountain Health Care, Inc.
OTHER
Vanderbilt University Medical Center
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Daniel Benjamin, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of Florida, Shands Children's Hospital
Gainesville, Florida, United States
Indiana University Health, Riley Hospital for Children
Indianapolis, Indiana, United States
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, United States
UMass Memorial Medical Center, Children's Center
Worcester, Massachusetts, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Saint Louis University, Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
University of New Mexico Children's Hospital
Albuquerque, New Mexico, United States
University of Buffalo, Oishei Children's Hospital
Buffalo, New York, United States
University of Rochester Medical Center, Golisano Children's Hospital
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Rainbow Babies and Children's Hospital, University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
MetroHealth System, Case CTSA
Cleveland, Ohio, United States
Oregon Health and Science University, Doernbecher Children's Hospital
Portland, Oregon, United States
Drexel University, St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States
University of Texas - Health Science Center San Antonio
San Antonio, Texas, United States
Primary Children's Medical Center- University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Boutzoukas AE, Olson R, Sellers MA, Fischer G, Hornik CD, Alibrahim O, Iheagwara K, Abulebda K, Bass AL, Irby K, Subbaswamy A, Zivick EE, Sweney J, Stormorken AG, Barker EE, Lutfi R, McCrory MC, Costello JM, Ackerman KG, Munoz Pareja JC, Dean JM, Abdelsamad N, Hanley DF Jr, Mould WA, Lane K, Stroud M, Feger BJ, Greenberg RG, Smith PB, Benjamin DK Jr, Hornik CP, Zimmerman KO, Becker ML. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience. Contemp Clin Trials. 2023 Feb;125:107067. doi: 10.1016/j.cct.2022.107067. Epub 2022 Dec 25.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00102267
Identifier Type: -
Identifier Source: org_study_id