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Trial registered on ANZCTR
Registration number
ACTRN12615000468527
Ethics application status
Approved
Date submitted
14/04/2015
Date registered
13/05/2015
Date last updated
4/11/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of Ketamine on Proinflammatory and Anti-inflammatory cytokine response in Pediatric cardiac surgery.
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Scientific title
In pediatric patients with congenital heart diseases undergoing cardiac surgery we will study the effect of intravenous ketamine injection on the Proinflammatory cytokines ( IL-6, IL-8, CRP and TNF-alpha) and anti0inflammatory cytokine (IL-10) release .
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Secondary ID [1]
286516
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
congenital heart disease
294735
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Condition category
Condition code
Anaesthesiology
295022
295022
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0
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Anaesthetics
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Cardiovascular
295190
295190
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In the first intervention group, anesthesia will be induced by Injection of intravenous Ketamine 1-2 mg/Kg, fentanyl 1-5 ug/Kg and rocuronium 0.5 mg/Kg then patient will be intubated and surgery will start.. Then anesthesia will be maintained by sevoflurane and additional doses of fentanyl and rocuronium as needed.
In the second intervention group, anesthesia will be also induced by Injection of intravenous Ketamine 1-2 mg/Kg, fentanyl 1-5 ug/Kg and rocuronium 0.5 mg/Kg and then Ketamine IV infusion will start immediately after induction of general anesthesia and intubation at a dose 50 ug/Kg/min., and will continue till weaning off the patient from the cardiopulmonary bypass. ( so the exact duration is not fixed and it depends on the duration from induction of anesthesia till weaning off bypass), this will be in addition to sevoflurane and additional doses of fentanyl and rocuronium as needed.
so the difference between the 2 intervention groups is administration of intravenous ketamine infusion during maintenance of anesthesia in the second intervention group.
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Intervention code [1]
291609
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Treatment: Drugs
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Intervention code [2]
291752
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Prevention
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Comparator / control treatment
Placebo group to be used .
In this placebo group, patients will not receive Ketamine at all and the proinflammatory and anti-inflammatory cytokine response will be studied
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Interleukin-6
Serum levels will be determined using commercially available sandwich Enzyme Linked-Immuno-Sorbent Assay (ELISA) kits (Invitrogen, CA, USA). All assays will be performed according to the manufacturer’s instruction.
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Assessment method [1]
294777
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Timepoint [1]
294777
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Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
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Primary outcome [2]
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Interleukin-8
Serum levels will be determined using commercially available sandwich Enzyme Linked-Immuno-Sorbent Assay (ELISA) kits (Invitrogen, CA, USA). All assays will be performed according to the manufacturer’s instruction.
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Assessment method [2]
294779
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Timepoint [2]
294779
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Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
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Primary outcome [3]
294780
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Tumour necrosis Factor ( TNF-alpha)
Serum levels will be determined using commercially available sandwich Enzyme Linked-Immuno-Sorbent Assay (ELISA) kits (Invitrogen, CA, USA). All assays will be performed according to the manufacturer’s instruction.
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Assessment method [3]
294780
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Timepoint [3]
294780
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Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
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Secondary outcome [1]
314021
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Interleukin-10
Serum levels will be determined using commercially available sandwich Enzyme Linked-Immuno-Sorbent Assay (ELISA) kits (Invitrogen, CA, USA). All assays will be performed according to the manufacturer’s instruction.
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Assessment method [1]
314021
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Timepoint [1]
314021
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Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
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Secondary outcome [2]
314022
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CRP ( C- reactive protein).
Serum concentration will be determined using immune-turbidimetric assay (Roche Diagnostic, Germany)
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Assessment method [2]
314022
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Timepoint [2]
314022
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Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
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Eligibility
Key inclusion criteria
All patients between one month and five years old undergoing on-pump cardiac surgeries for congenital heart diseases will be included.
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Minimum age
1
Months
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Maximum age
5
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1- Patients with history of recent preoperative inflammation or infection.
2- patients with history of preoperative steroid therapy.
3- Patients undergoing cardiac surgery procedures requring total circulatory arrest.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/05/2015
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
10/12/2015
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Date of last data collection
Anticipated
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Actual
15/12/2015
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Sample size
Target
66
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Accrual to date
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Final
66
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Recruitment outside Australia
Country [1]
6812
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Saudi Arabia
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State/province [1]
6812
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Jeddah
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Funding & Sponsors
Funding source category [1]
291095
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Hospital
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Name [1]
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King Faisal Specialist Hospital and Research Center-
( Jeddah branch)
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Address [1]
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Saudi Arabia
Jeddah
Alrawda district- Alrawda street
P.O. Box: 40047
ZIP code: Jeddah 21499
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Country [1]
291095
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Saudi Arabia
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Primary sponsor type
Individual
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Name
Tamer Hamed Aly Ibrahim
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Address
King Faisal Specialist Hospital and Research Center
( Jeddah Branch)
Saudi Arabia
P.O box: 40047 (MBC- J#22)
Jeddah 21499
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Country
Saudi Arabia
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Secondary sponsor category [1]
289772
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Individual
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Name [1]
289772
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Hassan Ahmed Saad
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Address [1]
289772
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King Faisal Specialist Hospital and Research Center
( Jeddah Branch)
Saudi Arabia
P.O box: 40047 (MBC- J#22)
Jeddah 21499
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Country [1]
289772
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Saudi Arabia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292677
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IRB- King Faisal Specialist Hospital and Research Center
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Ethics committee address [1]
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King Faisal Specialist Hospital and Research Center ( Jeddah Branch) Saudi Arabia P.O box: 40047 Jeddah 21499
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Ethics committee country [1]
292677
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Saudi Arabia
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Date submitted for ethics approval [1]
292677
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Approval date [1]
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02/04/2014
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Ethics approval number [1]
292677
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IRB 2014-01.1
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Summary
Brief summary
Corrective surgery for congenital heart defects in children frequently requires cardiopulmonary bypass (CPB). The combination of anesthesia, surgical stress and CPB evokes an acute systemic inflammatory response with activation of cellular and humoral cascades. This response activates pathways that can lead to organ failure, which increases post-operative morbidity. The inflammatory response to CBP is often evaluated by means of inflammatory markers in the peripheral blood such as cytokines, acute phase proteins and white blood cells. The most important cytokines in relation to cardiac surgery are tissue necrosis factor 8 ( TNF 8), Interleukin(IL)-6, IL-8 and IL-10. Ketamine possesses several anti-inflammatory properties. It reduces neutrophil integrin expression and leucocyte-endothelial interaction and also inhibits monocyte and macrophage function. ketamine attenuates the in vitro synthesis of pro-inflammatory cytokines such as TNF8, Il-6 and IL-8 in the blood. In this study we will examine the effect of ketamine on the inflammatory response in pediatric patients undergoing on-pump cardiac surgery for congenital heart defects. We will also examine if this affects the need and the duration of inotropic drugs infusion and the length of ICU and hospital stay.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Tamer Hamed Aly Ibrahim
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Address
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King Faisal Specialist Hospital and Research center
( Jeddah Branch)
Jeddah- Saudi Arabia
P.O Box: 40047 ( MBC-J #22)
Jeddah: 21449
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Country
56450
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Saudi Arabia
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Phone
56450
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+966503845700
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Fax
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Email
56450
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[email protected]
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Contact person for public queries
Name
56451
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Tamer Hamed Aly Ibrahim
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Address
56451
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King Faisal Specialist Hospital and Research center
( Jeddah Branch)
Jeddah- Saudi Arabia
P.O Box: 40047 ( MBC-J #22)
Jeddah: 21449
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Country
56451
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Saudi Arabia
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Phone
56451
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+966503845700
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Fax
56451
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Email
56451
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[email protected]
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Contact person for scientific queries
Name
56452
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Tamer Hamed Aly Ibrahim
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Address
56452
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King Faisal Specialist Hospital and Research center
( Jeddah Branch)
Jeddah- Saudi Arabia
P.O Box: 40047 ( MBC-J #22)
Jeddah: 21449
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Country
56452
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Saudi Arabia
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Phone
56452
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+966503845700
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Fax
56452
0
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Email
56452
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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