NCT03012997

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

December 9, 2016

Last Update Submit

January 5, 2017

Conditions

Heart Valve DiseaseCoronary (Artery) Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Partial pressure of oxygen(mmHg),

    72 hours

  • Partial pressure of carbondioxide(mm Hg)

    72 hours

  • lactate (mmol/l)

    72 hours

  • ph values

    72 hours

  • systolic arterial pressure (mmHg),

    72 hours

  • +3 more secondary outcomes

Study Arms (2)

Active Comparator: 40% oxygen

ACTIVE COMPARATOR

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

Other: Fraction of inspired oxygen 40%

Active Comparator: 100% oxygen

ACTIVE COMPARATOR

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.

Other: Fraction of inspired oxygen 100%

Interventions

Fraction of inspired oxygen 40%OTHER
Active Comparator: 40% oxygen
Fraction of inspired oxygen 100%OTHER
Active Comparator: 100% oxygen

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA II-III
  • Patients with EF higher than 50%.
  • patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kartal Kosuyolu Training and Research Hospital

Istanbul, Marmara, 35000, Turkey (Türkiye)

RECRUITING

Kartal Kosuyolu Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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: 27001081BACKGROUND

MeSH Terms

Conditions

Heart Valve DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Guniz Koksal, Professor

    Istanbul University

    STUDY DIRECTOR

Central Study Contacts

Guniz Koksal, Professor

CONTACT

05322067777gunizkoksal@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Anesthesiologist

Study Record Dates

First Submitted

December 9, 2016

First Posted

January 6, 2017

Study Start

December 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

TU(2)