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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04080219

Enrollment

414

Registered

2019-09-06

Start date

2018-12-19

Completion date

2021-12-31

Last updated

2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

Keywords

valvular heart surgery, cardiopulmonary bypass

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)	15 minutes after anesthetic induction	Urinary NGAL measurement by ELISA after anesthetic induction

Countries

South Korea

Outcome results