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Completed

NCT Number: NCT04679337

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

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yeungnam University Medical Center

Daegu, 42415, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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%)

Treatment and study plan

Primary outcomes

  1. rrSO2 and cvSO2

    Time frame: up tp 30 days after surgery

    Correlation between renal oxygen saturation and central venous oxygen saturation

Secondary outcomes

  1. rrSO2 and rcSO2

    Time frame: up to 30 days after surgery

    Correlation between renal oxygen saturation and cerebral oxygen saturation

Sponsors and collaborators

Lead sponsor

Yeungnam University College of Medicine

Other

Registry information

Official study title

Changes in Renal Tissue Oxygen Saturation and Its Relationship With Central Venous and Cerebral Oxygen Saturation During Off-pump Coronary Artery Bypass Graft Surgery

Acronym: OPCAB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2020
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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