- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03012997
Effects of Hyperoxia on Open Heart Surgery
Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.
Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guniz Koksal, Professor
- Phone Number: 05322067777
- Email: gunizkoksal@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Kartal Kosuyolu Training and Research Hospital
-
Contact:
- emre gurcu, Specialist
- Phone Number: 905058917800
- Email: emregurcu@gmail.com
-
-
Marmara
-
Istanbul, Marmara, Turkey, 35000
- Recruiting
- Kartal Kosuyolu Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA II-III
- Patients with EF higher than 50%.
- patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)
Exclusion Criteria:
- patients with Diabetes Mellitus
- patients with COPD
- Patients with Cerebral Vascular Disease
- Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and hypercarbia (PaCO2 higher than 45 mmHg)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active Comparator: 40% oxygen
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.
|
|
ACTIVE_COMPARATOR: Active Comparator: 100% oxygen
Patients in this group will be ventilated with fraction of inspired oxygen during 100% induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
Time Frame: 72 hours
|
As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial pressure of oxygen(mmHg),
Time Frame: 72 hours
|
Partial pressure of oxygen(mmHg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
Partial pressure of carbondioxide(mm Hg)
Time Frame: 72 hours
|
,Partial pressure of carbondioxide(mm Hg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
lactate (mmol/l)
Time Frame: 72 hours
|
lactate (mmol/l) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
ph values
Time Frame: 72 hours
|
ph values in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
systolic arterial pressure (mmHg),
Time Frame: 72 hours
|
systolic arterial pressure (mmHg), levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
diastolic arterial pressure (mmHg)
Time Frame: 72 hours
|
diastolic arterial pressure (mmHg) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
Oxygen saturation (%)
Time Frame: 72 hours
|
Oxygen saturation (%) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
heart rate (beat/min)
Time Frame: 72 hours
|
heart rate (beat/min) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
|
72 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Guniz Koksal, Professor, Istanbul University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KK01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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