NCT04679337

Brief Summary

The purpose of this study is to evaluate changes in renal oxygen saturation (rrSO2) and its relationship with central venous oxygen saturation (cvSO2), cerebral cortical oxygen saturation (rcSO2), and hemodynamic parameters while displacing the heart for each coronary anastomosis in 19-80 year old adult patients receiving off-pump coronary artery bypass graft surgery (OPCAB) under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

December 8, 2020

Last Update Submit

February 13, 2023

Conditions

Acute Kidney Injury

Keywords

Acute Kidney InjuryOximetryCoronary Artery Bypass, Off-Pump

Outcome Measures

Primary Outcomes (1)

  • rrSO2 and cvSO2

    Correlation between renal oxygen saturation and central venous oxygen saturation

    up tp 30 days after surgery

Secondary Outcomes (1)

  • rrSO2 and rcSO2

    up to 30 days after surgery

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients between 19 and 80 years old undergoing off-pump coronary artery bypass graft surgery due to coronary artery ostructive disease

You may qualify if:

  • clinical diagnosis of coronary artery obstructive disease
  • undergoing off-pump coronary artery bypass graft surgery

You may not qualify if:

  • renal artery stenosis
  • Hyperbilirubinemia (total bilirubin\> 1.2 mg/dl)
  • Kidney disease (serum creatinine 1.5 mg/dl) or chronic kidney failure
  • Carotid artery stenosis (\> 60%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 22, 2020

Study Start

December 10, 2020

Primary Completion

December 3, 2022

Study Completion

December 3, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

KR(1)