Effects of Hyperoxia on Open Heart Surgery

NCT03012997 — Not applicable, Unknown, 100 participants, Istanbul University

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Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery

Registry	NCT03012997
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, screening
Enrollment	100 (Estimated)
Sponsor	Istanbul University (Other); collaborators: Koşuyolu Kartal Heart Training and Research Hospital
Conditions	Heart Valve Disease, Coronary (Artery) Disease
Interventions	Fraction of inspired oxygen 40%, Fraction of inspired oxygen 100% (Other)
Dates	start 2016-12-01, primary completion 2017-04-01 (estimated), completion 2017-04-01 (estimated), first posted 2017-01-06, last updated 2017-01-06
Locations	2 sites in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Active Comparator: 40% oxygen	Active comparator	Other: Fraction of inspired oxygen 40%	Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.
Active Comparator: 100% oxygen	Active comparator	Other: Fraction of inspired oxygen 100%	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.

Fraction of inspired oxygen 40% (Other)
Fraction of inspired oxygen 100% (Other)

+Outcome measures

Primary outcomes

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 [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

Secondary outcomes

Partial pressure of oxygen(mmHg), [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.
Partial pressure of carbondioxide(mm Hg) [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.
lactate (mmol/l) [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.
ph values [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.
systolic arterial pressure (mmHg), [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.
diastolic arterial pressure (mmHg) [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.
Oxygen saturation (%) [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.
heart rate (beat/min) [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.

+Eligibility

Sex: All, ages: 20 Years to 65 Years

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)

+Locations (2)

Facility	City	Country	Status
Kartal Kosuyolu Training and Research Hospital	Istanbul, Marmara	Turkey (Türkiye)	Recruiting
Kartal Kosuyolu Training and Research Hospital	Istanbul	Turkey (Türkiye)	Recruiting

+Publications

Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21. PMID 27001081

+Investigators

Guniz Koksal, Professor, Study director, Istanbul University