Trial Review

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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.
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 .
Secondary ID [1] 286516 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
congenital heart disease 294735 0
Condition category
Condition code
Anaesthesiology 295022 295022 0 0
Anaesthetics
Cardiovascular 295190 295190 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291609 0
Treatment: Drugs
Intervention code [2] 291752 0
Prevention
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
Control group
Placebo

Outcomes
Primary outcome [1] 294777 0
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.
Timepoint [1] 294777 0
Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
Primary outcome [2] 294779 0
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.
Timepoint [2] 294779 0
Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
Primary outcome [3] 294780 0
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.
Timepoint [3] 294780 0
Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
Secondary outcome [1] 314021 0
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.
Timepoint [1] 314021 0
Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.
Secondary outcome [2] 314022 0
CRP ( C- reactive protein).
Serum concentration will be determined using immune-turbidimetric assay (Roche Diagnostic, Germany)
Timepoint [2] 314022 0
Baseline.
After coming off cardiopulmonary bypass.
6 hours after coming off cardiopulmonary bypass.
24 hours after coming off cardiopulmonary bypass.

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.
Minimum age
1 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2015
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
10/12/2015
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
66
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 6812 0
Saudi Arabia
State/province [1] 6812 0
Jeddah

Funding & Sponsors
Funding source category [1] 291095 0
Hospital
Name [1] 291095 0
King Faisal Specialist Hospital and Research Center-
( Jeddah branch)
Country [1] 291095 0
Saudi Arabia
Primary sponsor type
Individual
Name
Tamer Hamed Aly Ibrahim
Address
King Faisal Specialist Hospital and Research Center
( Jeddah Branch)
Saudi Arabia
P.O box: 40047 (MBC- J#22)
Jeddah 21499
Country
Saudi Arabia
Secondary sponsor category [1] 289772 0
Individual
Name [1] 289772 0
Hassan Ahmed Saad
Address [1] 289772 0
King Faisal Specialist Hospital and Research Center
( Jeddah Branch)
Saudi Arabia
P.O box: 40047 (MBC- J#22)
Jeddah 21499
Country [1] 289772 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292677 0
IRB- King Faisal Specialist Hospital and Research Center
Ethics committee address [1] 292677 0
King Faisal Specialist Hospital and Research Center
( Jeddah Branch)
Saudi Arabia
P.O box: 40047
Jeddah 21499
Ethics committee country [1] 292677 0
Saudi Arabia
Date submitted for ethics approval [1] 292677 0
Approval date [1] 292677 0
02/04/2014
Ethics approval number [1] 292677 0
IRB 2014-01.1

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56450 0
Dr Tamer Hamed Aly Ibrahim
Address 56450 0
King Faisal Specialist Hospital and Research center
( Jeddah Branch)
Jeddah- Saudi Arabia
P.O Box: 40047 ( MBC-J #22)
Jeddah: 21449
Country 56450 0
Saudi Arabia
Phone 56450 0
+966503845700
Fax 56450 0
Email 56450 0
dr_tamerhamed@yahoo.com
Contact person for public queries
Name 56451 0
Dr Tamer Hamed Aly Ibrahim
Address 56451 0
King Faisal Specialist Hospital and Research center
( Jeddah Branch)
Jeddah- Saudi Arabia
P.O Box: 40047 ( MBC-J #22)
Jeddah: 21449
Country 56451 0
Saudi Arabia
Phone 56451 0
+966503845700
Fax 56451 0
Email 56451 0
dr_tamerhamed@yahoo.com
Contact person for scientific queries
Name 56452 0
Dr Tamer Hamed Aly Ibrahim
Address 56452 0
King Faisal Specialist Hospital and Research center
( Jeddah Branch)
Jeddah- Saudi Arabia
P.O Box: 40047 ( MBC-J #22)
Jeddah: 21449
Country 56452 0
Saudi Arabia
Phone 56452 0
+966503845700
Fax 56452 0
Email 56452 0
dr_tamerhamed@yahoo.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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