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CompletedNCT04679337OPCABUpdated Feb 14, 2023

Renal Oxygen Saturation During Off-pump Coronary Artery Bypass Graft Surgery

An observational study in Acute Kidney Injury, sponsored by Yeungnam University College of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Yeungnam University College of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

In the current clinical trial, systemic perfusion and oxygenation through hemodynamic variables such as cardiac index and mean arterial pressure, and central venous oxygen saturation (cvSO2) are monitored during surgery. However, it has not been studied whether the hemodynamic parameters and systemic oxygen saturation adequately reflect the perfusion and oxygen saturation of the kidney. Although there are various new serum biomarkers that are known to reflect renal function or damage, they are not real-time monitoring of renal function because they take time and cost to collect and analyze.

Near-infrared spectroscopy (NIRS) measures the distribution of oxygenated hemoglobin and deoxygenated hemoglobin in tissues by sending two different near-infrared wavelengths (730 and 810 nm) from the sensor. It is a device that can continuously monitor the oxygen supply-demand balance to a specific region non-invasively. NIRS is mainly used to measure the oxygen demand-supply balance of the cerebral tissue by attaching a sensor to the forehead in the surgical patient. Since it is known to be closely related to the reduction of cerebral oxygen saturation during surgery and the occurrence of postoperative cognitive dysfunction, it is used as an indispensable monitoring device to prevent neurological complications in heart surgery patients. Recently, with technological advances, it has become possible to measure oxygen saturation by attaching sensors to various body tissues other than the brain. When monitored with an NIRS sensor attached to the kidney, the relationship between renal oxygen saturation reduction and postoperative acute kidney injury (AKI) in children and adult patients undergoing heart surgery was reported. However, so far, the effects of systemic hemodynamic and oxygen saturation changes during the displacement of heart for coronary anastomosis during OPCAB on the oxygen saturation in the cerebral cortex and kidney, have not been studied. In addition, it is not known whether the cerebral cortical oxygen saturation (rcSO2), which is commonly used in heart surgery, can reflect the renal oxygen saturation (rrSO2).

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.

02

Conditions studied

  • Acute Kidney Injury

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Keywords

  • Acute Kidney Injury
  • Oximetry
  • Coronary Artery Bypass, Off-Pump
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's enrollment of 46 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Yeungnam University College of Medicine is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • renal artery stenosis
  • Hyperbilirubinemia (total > 1.2 mg/dl)
  • Kidney disease (serum creatinine 1.5 mg/dl) or chronic kidney failure
  • Carotid artery stenosis (> 60%)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. rrSO2 and cvSO2

    Correlation between renal oxygen saturation and central venous oxygen saturation

    Time frame: up tp 30 days after surgery

Secondary outcomes

  1. rrSO2 and rcSO2

    Correlation between renal oxygen saturation and cerebral oxygen saturation

    Time frame: up to 30 days after surgery

07

Study locations

1 site
  • Yeungnam University Medical Center
    Daegu, 42415, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04679337
Lead sponsor
Yeungnam University College of Medicine
Responsible party
Sung Mee Jung (Professor, Yeungnam University College of Medicine) — Principal investigator
First posted
Dec 22, 2020
Start date
Dec 10, 2020
Primary completion
Dec 3, 2022
Completion
Dec 3, 2022
Last update
Feb 14, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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