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

• Conditions: Valvular Heart Disease

• Registration Number: NCT04080219
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

1. Adult patient aged more than 20 years
2. Patients undergoing valvular heart surgery.

Exclusion Criteria

1. Emergency
2. Simultaneous surgery with coronary artery bypass graft
3. Previous history of cerebrovascular accident
4. Previous history of sleep disordered breathing (diagnosis & treatment)
5. Previous history of tracheostomy
6. Previous history of surgical treatment of airway (ex: nasopharyngeal cancer)
7. Preoperative oxygen supplement therapy
8. Patients who have participated in other clinical studies that may affect prognosis
9. Patients who cannot read and agree to informed consent (ex: foreigners, cognitive dysfunction)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative acute kidney injury	Postoperative 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)	Post-CPB 24hours	Urinary NGAL measurement by ELISA after 24hours after cardiopulmonary bypass discontinuation

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of