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Dexmedetomidine Effect on Mitochondrial Function

8. maj 2018 opdateret af: James O'Leary, The Hospital for Sick Children

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.

The investigators hypothesize that in addition to a known sympatholytic effect, intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and structure attenuating ischaemia-reperfusion and end-organ injury for children with non cyanotic congenital heart defects having corrective heart surgery.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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:

  1. 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.
  2. 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

36

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Rekruttering
        • Hospital for Sick Children
        • Ledende efterforsker:
          • James D O'Leary, MBBCh
        • Underforsker:
          • John Coles, MD
        • Underforsker:
          • Jason T Maynes, MD PhD
        • Underforsker:
          • Daniel Stocki

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 måneder til 3 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Medicin: 0,9% NaCl
Andre navne:
  • Normal saltvand
Eksperimentel: 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.
Medicin: Dexmedetomidine
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 navne:
  • Precedex

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mitochondrial function (use high content imaging (HCI)
Tidsramme: Intraoperative
The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage.
Intraoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Creatinine level (Marker of acute renal injury)
Tidsramme: Postoperative day 1
Marker of acute renal injury
Postoperative day 1
Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography)
Tidsramme: 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)
Tidsramme: Postoperative day 1
Duration and dose of inotropes and vasopressors after surgery
Postoperative day 1

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Analgesic effects (Morphine equivalent dose of narcotics consumed)
Tidsramme: 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)
Tidsramme: Perioperative (from induction of anesthesia for 24 hours)
Duration of intubation.
Perioperative (from induction of anesthesia for 24 hours)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Hospital for Sick Children

Efterforskere

  • Ledende efterforsker: James D O'Leary, MBBCh, The Hospital for Sick Children

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2014

Primær færdiggørelse (Forventet)

1. december 2019

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

18. november 2014

Først indsendt, der opfyldte QC-kriterier

21. november 2014

Først opslået (Skøn)

24. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1000044746

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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Kliniske forsøg med Komplikation af anæstesi

Kliniske forsøg med 0,9% NaCl

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