Effects of Hyperoxia on Open Heart Surgery

Heart Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03012997
• Other study ID #: KK01
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2016
• Last updated: January 5, 2017
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: January 2017
• Source: Istanbul University
• Contact: Guniz Koksal, Professor
• Phone: 05322067777
• Email: gunizkoksal[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Coronary (Artery) Disease
• Coronary Disease
• Heart Valve Disease
• Heart Valve Diseases
• Hyperoxia

Intervention

Other:
• Fraction of inspired oxygen 40%

• Fraction of inspired oxygen 100%

Locations

Country	Name	City	State
Turkey	Kartal Kosuyolu Training and Research Hospital	Istanbul	Marmara
Turkey	Kartal Kosuyolu Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Kosuyolu Kartal Heart Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Çakatay 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	Partial pressure of oxygen(mmHg),	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	No
Secondary	Partial pressure of carbondioxide(mm Hg)	,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	No
Secondary	lactate (mmol/l)	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	No
Secondary	ph values	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	No
Secondary	systolic arterial pressure (mmHg),	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	No
Secondary	diastolic arterial pressure (mmHg)	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	No
Secondary	Oxygen saturation (%)	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	No
Secondary	heart rate (beat/min)	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	No