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Effects of Hyperoxia on Open Heart Surgery

Primary Purpose

Heart Valve Disease, Coronary (Artery) Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fraction of inspired oxygen 40%
Fraction of inspired oxygen 100%
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Heart Valve Disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kartal Kosuyolu Training and Research HospitalRecruiting
  • Kartal Kosuyolu Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active Comparator: 40% oxygen

Active Comparator: 100% oxygen

Arm Description

Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 9, 2016
Last Updated
January 5, 2017
Sponsor
Istanbul University
Collaborators
Koşuyolu Kartal Heart Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03012997
Brief Title
Effects of Hyperoxia on Open Heart Surgery
Official Title
Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Koşuyolu Kartal Heart Training and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Disease, Coronary (Artery) Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: 40% oxygen
Arm Type
Active Comparator
Arm Description
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.
Arm Title
Active Comparator: 100% oxygen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fraction of inspired oxygen 40%
Intervention Type
Other
Intervention Name(s)
Fraction of inspired oxygen 100%
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Partial pressure of oxygen(mmHg),
Description
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.
Time Frame
72 hours
Title
Partial pressure of carbondioxide(mm Hg)
Description
,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.
Time Frame
72 hours
Title
lactate (mmol/l)
Description
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.
Time Frame
72 hours
Title
ph values
Description
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.
Time Frame
72 hours
Title
systolic arterial pressure (mmHg),
Description
systolic arterial pressure (mmHg), levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Time Frame
72 hours
Title
diastolic arterial pressure (mmHg)
Description
diastolic arterial pressure (mmHg) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Time Frame
72 hours
Title
Oxygen saturation (%)
Description
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.
Time Frame
72 hours
Title
heart rate (beat/min)
Description
heart rate (beat/min) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guniz Koksal, Professor
Phone
05322067777
Email
gunizkoksal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guniz Koksal, Professor
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
Kartal Kosuyolu Training and Research Hospital
City
Istanbul
State/Province
Marmara
ZIP/Postal Code
35000
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kartal Kosuyolu Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emre gurcu, Specialist
Phone
905058917800
Email
emregurcu@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27001081
Citation
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.
Results Reference
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Effects of Hyperoxia on Open Heart Surgery

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