- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02299063
Dexmedetomidine Effect on Mitochondrial Function
The Protective Effect of the α2-agonist Dexmedetomidine on Mitochondrial Structure and Function for Children With Non-cyanotic Congenital Heart Defects Having Cardiac Surgery: A Randomized Controlled Trial.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
PICO: For children with non cyanotic congenital heart defects having corrective heart surgery (P) does intraoperative dexmedetomidine (I) reduce real-time changes in mitochondrial function and content (O) compared with children not receiving dexmedetomidine (C).
The study drug (dexmedetomidine or placebo) will be mixed in a standardized syringe of 4mcg/mL for active syringes or 50mL 0.9% sodium chloride for placebo. Blinded syringes will be prepared by the Research Support Pharmacy.
Administration is via the existing central venous line. A bolus dose of 0.125mL/kg (0.5 mcg/kg dexmedetomidine) infused over 10 minutes will be administered, followed by a continuous infusion for the duration of the surgery. The dexmedetomidine/placebo continuous infusion (CI) dose will run at 0.15mL/kg/hr (0.6 mcg/kg/hr dexmedetomidine).
Blood samples will be obtained from each child at three points in the operating room: 1) after the induction of anesthesia, 2) at the first separation from CPB (prior to administration of blood products), and 3) at the end of the surgery.
Samples obtained will be analyzed for mitochondrial function and morphology, total cellular mitochondrial biomass, and mitochondrial deoxyribonucleic acid (mtDNA) damage:
- After isolating lymphocytes, we will use high content imaging (HCI) to assess mitochondrial function and morphology. The lymphocytes will be stained with tetramethylrhodamine methyl ester (TMRM), which stains mitochondria in proportion to mitochondrial membrane potential, giving a metric for mitochondrial function. In addition, the cells will be stained with MitoTracker Green®, which can be used to assess mitochondrial morphology. Mitochondrial morphology will be quantified in a non-biased fashion using a mathematical image analysis algorithm.
- After extraction of genomic DNA, total cellular mitochondrial biomass and mitochondrial DNA damage will be measured using traditional and long-patch quantitative polymerase chain reaction (PCR).
Myocardial tissue will be also collected prior to closure of the atriotomy. Samples will be placed into 3% buffered glutaraldehyde at the time of biopsy, and imaging of mitochondrial structure using electron microscopy will be performed.
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- Rekruttering
- Hospital for Sick Children
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Hovedetterforsker:
- James D O'Leary, MBBCh
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Underetterforsker:
- John Coles, MD
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Underetterforsker:
- Jason T Maynes, MD PhD
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Underetterforsker:
- Daniel Stocki
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- aged between 3 - 36 months
- having primary corrective heart surgery
Exclusion Criteria:
- recent surgery (< 3 months)
- previous chemotherapy
- previous transfusion of blood products
- neurodevelopmental disorders (including Trisomy 21)
- supplemental oxygen requirement (< 3 months)
- asthma requiring regular therapy
- obstructive sleep apnea
- the presence of concurrent infection or inflammation
- a known allergy to dexmedetomidine hydrochloride
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo (0.9% Saline)
0.9% Saline: bolus dose of 0.125mL/kg infused over 10 minutes, followed by a continuous infusion (CI) dose at 0.15mL/kg/hr for the duration of surgery.
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Andre navn:
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Eksperimentell: Dexmedetomidine
Dexmedetomidine: bolus dose of 0.5 mcg/kg infused over 10 minutes, followed by a continuous infusion (CI) dose at 0.6 mcg/kg/hr for the duration of surgery.
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A bolus dose of 0.5 mcg/kg infused over 10 minutes will be administered, followed by a continuous infusion for the duration of the surgery at 0.6 mcg/kg/hr.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mitochondrial function (use high content imaging (HCI)
Tidsramme: Intraoperative
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The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage.
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Intraoperative
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Creatinine level (Marker of acute renal injury)
Tidsramme: Postoperative day 1
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Marker of acute renal injury
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Postoperative day 1
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Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography)
Tidsramme: Postoperative day 1
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Left ventricular ejection fraction measured by trans-thoracic echocardiography
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Postoperative day 1
|
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Inotropes and vasopressors (Duration and dose of inotropes and vasopressors after surgery)
Tidsramme: Postoperative day 1
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Duration and dose of inotropes and vasopressors after surgery
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Postoperative day 1
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Analgesic effects (Morphine equivalent dose of narcotics consumed)
Tidsramme: Perioperative (from induction of anesthesia for 24 hours)
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Morphine equivalent dose of narcotics consumed
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Perioperative (from induction of anesthesia for 24 hours)
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Sedative effects (Duration of intubation)
Tidsramme: Perioperative (from induction of anesthesia for 24 hours)
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Duration of intubation.
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Perioperative (from induction of anesthesia for 24 hours)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: James D O'Leary, MBBCh, The Hospital for Sick Children
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Postoperative komplikasjoner
- Iskemi
- Reperfusjonsskade
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Adrenerge alfa-2-reseptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Hypnotika og beroligende midler
- Dexmedetomidin
Andre studie-ID-numre
- 1000044746
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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