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

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04080219
• Other study ID #: 4-2018-1017
• Status: Recruiting
• Start date: December 19, 2018
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Diseases
• Heart Valve Diseases
• Sleep Apnea Syndromes
• Valvular Heart Disease

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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