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

NCT ID: NCT04080219

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 414 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2021-12-31

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.

Conditions

Valvular Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal

Patients with Oxygen desaturation index \<5

No interventions assigned to this group

Sleep-disordered breathing

Patients with Oxygen desaturation index ≥5

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Sarah Soh, MD

Role: primary

yeonchoo@yuhs.ac

82-10-5108-0118

Other Identifiers

4-2018-1017

Identifier Type: -

Identifier Source: org_study_id