NCT04627220

Brief Summary

We aimed to measure the changes in your blood values caused by different but safe oxygen values used by us during your heart surgery under laboratory conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

November 3, 2020

Last Update Submit

November 7, 2020

Conditions

Keywords

cardiovascular surgeryantioxidanttiyol-disülfid homeostasisischemia modified albumin

Outcome Measures

Primary Outcomes (1)

  • assessment of oxidative damage

    To measure the degree of oxidative damage in the patient's blood at different oxygen values used in cardiac bypass surgeries with thiol disulfide homeostasis and ischemia-modified albumin at times determined.

    48 hours after operation

Study Arms (2)

group 1

Group 1: Pressure of arterial oxygen\> 200 mmHg during the coronary surgery

Diagnostic Test: taken venous sample

group 2

Group 2: Pressure of arterial oxygen\<200 mmHg and \>80 mmHg during the coronary surgery

Diagnostic Test: taken venous sample

Interventions

taken venous sampleDIAGNOSTIC_TEST

Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.

group 1group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

128 patients scheduled for cardiac surgery

You may qualify if:

  • patient scheduled for cardiac surgery
  • ASA\>3
  • Aged 18-75 years

You may not qualify if:

  • those with valvular disease
  • EF\<%40
  • BMI\>40 kg/m2
  • presence of arrhythmia that impairs hemodynamics
  • previous history of cerebrovascular
  • diagnosed with end-stage organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, 60160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ümran K Karaca, md

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Tuğba O Onur, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Şeyda Ö Özgünay, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Filiz A Ata, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Canan Y Yılmaz, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Şermin E Eminoğlu, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Halil Erkan S Sayan, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Yasemin Ü Üstündağ, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR
  • Anıl O Onur, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 13, 2020

Study Start

January 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations