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Trial registered on ANZCTR


Registration number
ACTRN12613000231741
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
27/02/2013
Date last updated
27/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of
Normoxic and Hyperoxic Cardiopulmonary Bypass on Oxidative Stress in
Cyanotic Pediatric Patients
Scientific title
The Effects of
Normoxic and Hyperoxic Cardiopulmonary Bypass on Oxidative Stress in
Cyanotic Pediatric Patients:A Randomized Controlled Trial
Secondary ID [1] 282008 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normoxic ,
Hyperoxic,
Cyanotic Pediatric Patients
288450 0
Condition category
Condition code
Cardiovascular 288792 288792 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty pediatric patients scheduled to undergo elective repair of cyanotic congenital heart diseases. Patient’s room air saturation is lower than %85. Patients’ ages differed from 6 months to 5 years (average 24, 22+/-17, 42 months). All patients were in stable condition. The study was approved by the Research Ethics Committee of institution. Patients with genetic syndromes, preoperative inotropic support and reoperative procedures were excluded from the study. The patients who were taken into the study were divided into two groups as controlled normoxic (n=15) (pO2:80-150 mmHg) (Group I), and hyperoxic (n=15) (pO2: 150-250 mmHg) (Group II). All operations were performed under CPB. The same anesthesia technique was used in both groups. CPB was initiated using standard Aortabicaval cannulation. Isothermic blood cardioplegia was administrated every 20 minutes during aortic cross clamping. Equal perfusion pressure was applied in operations. After anesthesia induction, FiO2 rate was applied as 21% in Group I, and it was applied as 50% in Group II. Arterial blood gas was seen every 15 min. intervals after CPB started. In Group I, PO2 rate in arterial blood gas was about 80-150 mmHg; and in Group II, it was about 150-250 mmHg. After the patients were taken into intensive care, ventilator settings were calibrated as Fi02 21% in Group I, and Fi02 50% in Group II; and routine intensive care protocols were applied. Patients’ MDA (Malondialdehit), GSH-Px (Glutathione Peroxidase), Glutathione reductase (GSH-R) rates were looked from the blood, which were drawn from the patients pre-operation (T1), during operation after CC in the 30th minute (T2), 10 minutes after aortic clamp was removed (T3) and 12th hours (T4). Also, measured values’ correlation with reference periods, pump duration, CC duration, extubation period and mortality rates was examined.


Intervention code [1] 286580 0
Treatment: Surgery
Intervention code [2] 286591 0
Prevention
Comparator / control treatment
Fifteen pediatric patients scheduled to undergo elective repair of cyanotic congenital heart diseases. Patient’s room air saturation is lower than %85. Patients’ ages differed from 6 months to 5 years (average 24, 22+/-17, 42 months). All patients were in stable condition. The study was approved by the Research Ethics Committee of institution. Patients with genetic syndromes, preoperative inotropic support and reoperative procedures were excluded from the study. Controlled normoxic (n=15) (pO2:80-150 mmHg) (Group I),All operations were performed under CPB. CPB was initiated using standard Aortabicaval cannulation. Isothermic blood cardioplegia was administrated every 20 minutes during aortic cross clamping. Equal perfusion pressure was applied in operations. After anesthesia induction, FiO2 rate was applied as 21% in Group I. Arterial blood gas was seen every 15 min. intervals after CPB started. In Group I, PO2 rate in arterial blood gas was about 80-150 mmHg. After the patients were taken into intensive care, ventilator settings were calibrated as Fi02 21% in Group I; and routine intensive care protocols were applied. Patients’ MDA (Malondialdehit), GSH-Px (Glutathione Peroxidase), Glutathione reductase (GSH-R) rates were looked from the blood, which were drawn from the patients pre-operation (T1), during operation after CC in the 30th minute (T2), 10 minutes after aortic clamp was removed (T3) and 12th hours (T4). Also, measured values’ correlation with reference periods, pump duration, CC duration, extubation period and mortality rates was examined.


Control group
Active

Outcomes
Primary outcome [1] 288932 0
Patients’ MDA (Malondialdehyde), GSH-Px (Glutathione Peroxidase), Glutathione reductase (GSH-R) rates were looked from the blood.
Timepoint [1] 288932 0
the patients pre-operation (T1), during operation after CC in the 30th minute (T2), 10 minutes after aortic clamp was removed (T3) and 12th hours (T4). Also, measured values’ correlation with reference periods, CPB time, ACC(aortic cross clamp) time.
Secondary outcome [1] 301383 0
extubation time assessed medical record data.
Timepoint [1] 301383 0
postoperative period.
Secondary outcome [2] 301405 0
mortality rates assessed with medical records data
Timepoint [2] 301405 0
postoperative period.

Eligibility
Key inclusion criteria
Elective total correction of cyanotic congenital heart diseases
Minimum age
6 Months
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acyanotic congenital heart diseases

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4880 0
Turkey
State/province [1] 4880 0
Saricam

Funding & Sponsors
Funding source category [1] 286783 0
University
Name [1] 286783 0
cukurova university
Address [1] 286783 0
University of Cukurova,Faculty of Medical,department of cardiovascular surgery,
01330-Adana
Country [1] 286783 0
Turkey
Primary sponsor type
University
Name
Cukurova University
Address
University of Cukurova, Faculty of Medical,Department of Cardiovascular Surgery,
01330-Saricam-Adana
Country
Turkey
Secondary sponsor category [1] 285566 0
Hospital
Name [1] 285566 0
balcali hospital
Address [1] 285566 0
University of Cukurova,Faculty of Medical, Department of Cardiovascular Surgery, Saricam-01330/Adana
Country [1] 285566 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288850 0
University of Cukurova,Faculty of Medical Local Ethics Committee
Ethics committee address [1] 288850 0
University of Cukurova,Faculty of Medical,Department of Cardiovascular Surgery,
Saricam-01330/Adana
Ethics committee country [1] 288850 0
Turkey
Date submitted for ethics approval [1] 288850 0
Approval date [1] 288850 0
20/06/2012
Ethics approval number [1] 288850 0

Summary
Brief summary
Study Aim: Cardiopulmonary Bypass with high oxygen levels may expose cyanotic children to reoxygenation injury. The superoxide radicals that are formed as a result of molecular oxygen and inflammatory response on cardiopulmonary bypass can cause a decrease in the high–energy phosphates, structural and functional changes in biomolecules. Antioxidant defense mechanism is inadequate in the children that have chronic hypoxia. Therefore, to avoid damage reoxygenation, various methods have been developed to reduce the formation of free oxygen radicals. Our study tested the hypothesis of oxidant damage via free radical generation during cardiopulmonary bypass on cyanotic pediatric patients. Materials and Methods: Cyanotic pediatric Patients (Fallot tetralogy)(n=30) were randomized to two treatment arms of the study. Cardiopulmonary bypass was performed as normoxic (pO2: 80-150mmHg) in Group I (n=15) and hyperoxic (pO2:150-250 mmHg) in Group II(n=15). Malondialdehyde, Glutathione peroxidase, Glutathione reductase were measured. Results: This study demonstrates that Malondialdehyde and antioxidant enzyme levels are higher in cyanotic infants with hyperoxic cardiopulmonary bypass. Conclusion: Routine clinical methods of cardiopulmonary bypass with a hyperoxemic may increase the reoxygenation injury in cyanotic children. The reoxygenation injury can be reduced by using a novel and simple Cardiopulmonary bypass strategy of controlled reoxygenation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38054 0
Dr Atakan Atalay
Address 38054 0
University of Cukurova,Faculty of Medical, Department of Cardiovascular Surgery,Saricam-01330/Adana
Country 38054 0
Turkey
Phone 38054 0
+90 322 3386815
Fax 38054 0
Email 38054 0
atakan1973@yahoo.com
Contact person for public queries
Name 38055 0
Prof Hafize Yaliniz
Address 38055 0
University of Cukurova,Faculty of Medical, Department of Cardiovascular Surgery,01330Saricam / Adana
Country 38055 0
Turkey
Phone 38055 0
+ 90 322 3386815
Fax 38055 0
Email 38055 0
hafize101@yahoo.com
Contact person for scientific queries
Name 38056 0
Dr Hafize Yaliniz
Address 38056 0
University of Cukurova,Faculty of Medical, Department of Cardiovascular Surgery,01330-Saricam/Adana
Country 38056 0
Turkey
Phone 38056 0
+90 322 3386815
Fax 38056 0
Email 38056 0
hafize101@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary