- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G1X8
- Rekrytering
- Hospital for Sick Children
-
Huvudutredare:
- James D O'Leary, MBBCh
-
Underutredare:
- John Coles, MD
-
Underutredare:
- Jason T Maynes, MD PhD
-
Underutredare:
- Daniel Stocki
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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.
|
Andra namn:
|
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Experimentell: 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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mitochondrial function (use high content imaging (HCI)
Tidsram: Intraoperative
|
The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage.
|
Intraoperative
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Creatinine level (Marker of acute renal injury)
Tidsram: Postoperative day 1
|
Marker of acute renal injury
|
Postoperative day 1
|
|
Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography)
Tidsram: Postoperative day 1
|
Left ventricular ejection fraction measured by trans-thoracic echocardiography
|
Postoperative day 1
|
|
Inotropes and vasopressors (Duration and dose of inotropes and vasopressors after surgery)
Tidsram: Postoperative day 1
|
Duration and dose of inotropes and vasopressors after surgery
|
Postoperative day 1
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Analgesic effects (Morphine equivalent dose of narcotics consumed)
Tidsram: Perioperative (from induction of anesthesia for 24 hours)
|
Morphine equivalent dose of narcotics consumed
|
Perioperative (from induction of anesthesia for 24 hours)
|
|
Sedative effects (Duration of intubation)
Tidsram: Perioperative (from induction of anesthesia for 24 hours)
|
Duration of intubation.
|
Perioperative (from induction of anesthesia for 24 hours)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: James D O'Leary, MBBCh, The Hospital for Sick Children
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Postoperativa komplikationer
- Ischemi
- Reperfusionsskada
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Analgetika, icke-narkotiska
- Adrenerga alfa-2-receptoragonister
- Adrenerga alfa-agonister
- Adrenerga agonister
- Hypnotika och lugnande medel
- Dexmedetomidin
Andra studie-ID-nummer
- 1000044746
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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