NCT02299063

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

5.1 years

First QC Date

November 18, 2014

Last Update Submit

May 8, 2018

Conditions

Complication of AnesthesiaIschaemia-reperfusion Injury

Keywords

MitochondriaDexmedetomidineHeart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

  • Mitochondrial function (use high content imaging (HCI)

    The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage.

    Intraoperative

Secondary Outcomes (3)

  • Creatinine level (Marker of acute renal injury)

    Postoperative day 1

  • Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography)

    Postoperative day 1

  • Inotropes and vasopressors (Duration and dose of inotropes and vasopressors after surgery)

    Postoperative day 1

Other Outcomes (2)

  • Analgesic effects (Morphine equivalent dose of narcotics consumed)

    Perioperative (from induction of anesthesia for 24 hours)

  • Sedative effects (Duration of intubation)

    Perioperative (from induction of anesthesia for 24 hours)

Study Arms (2)

Placebo (0.9% Saline)

PLACEBO COMPARATOR

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.

Drug: 0.9% NaCl

Dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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.

Also known as: Precedex
Dexmedetomidine
0.9% NaClDRUG
Also known as: Normal Saline
Placebo (0.9% Saline)

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged between 3 - 36 months
  • having primary corrective heart surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

RECRUITING

MeSH Terms

Conditions

Reperfusion InjuryHeart Defects, Congenital

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • James D O'Leary, MBBCh

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James D O'Leary, MBBCh

CONTACT

(416) 813-1500james.oleary@sickkids.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 24, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)