The Impact of Sleep-disordered Breathing on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery

Study Overview
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Brief Summary
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Sleep-disordered breathing has a prevalence of 30 80% in patients with heart diseases. Various studies have revealed a correlation between the incidence and various diseases such as heart failure, hypertension, diabetes, and cerebral infarction. Postoperative acute kidney injury after heart surgery is one of the major complications with incidence with 40 50%, however, there has been no preventive method or treatment yet. Recently, several studies have been published that have shown a correlation between sleep-disordered breathing and renal impairment. In general, sleep-disordered breathing can be regulated easily with continues positive expiratory pressure, which means that early diagnosis and treatment of sleep-disordered breathing might help to reduce the incidence of postoperative acute kidney injury and improve patients' prognosis. In this study, the investigators investigate the impact of sleep-disordered breathing (diagnosed by oxygen desaturation index ≥5) on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.

Official Title
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The Impact of Sleep-disordered Breathing on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery: a Prospective Observational Study

Conditions
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Valvular Heart Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient aged more than 20 years Patients undergoing valvular heart surgery. Exclusion Criteria: Emergency Simultaneous surgery with coronary artery bypass graft Previous history of cerebrovascular accident Previous history of sleep disordered breathing (diagnosis & treatment) Previous history of tracheostomy Previous history of surgical treatment of airway (ex: nasopharyngeal cancer) Preoperative oxygen supplement therapy Patients who have participated in other clinical studies that may affect prognosis Patients who cannot read and agree to informed consent (ex: foreigners, cognitive dysfunction)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>Patients with Oxygen desaturation index <5 | |
| Sleep-disordered breathing<br>Patients with Oxygen desaturation index ≥5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative acute kidney injury | Postoperative acute kidney injury development defined by KDIGO criteria for postoperative 7 days. -KDIGO(Kidney Disease Improving Global Outcomes) is the global nonprofit organization developing and implementing evidence-based clinical practice guidelines in kidney disease. | Postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay) | Urinary NGAL measurement by ELISA after anesthetic induction | 15 minutes after anesthetic induction | 
| Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay) | Urinary NGAL measurement by ELISA after 6hours after cardiopulmonary bypass discontinuation | Post-CPB 6hours | 
| Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay) | Urinary NGAL measurement by ELISA after 24hours after cardiopulmonary bypass discontinuation | Post-CPB 24hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valvular heart surgery, cardiopulmonary bypass