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

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.

Study Overview

• Status: Unknown
• Conditions: Valvular Heart Disease

• Study Type: Observational
• Enrollment (Anticipated): 414

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Sarah Soh, MD; Phone Number: 82-10-5108-0118; Email: yeonchoo@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing valvular heart surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normal; Patients with Oxygen desaturation index <5
Sleep-disordered breathing; Patients with Oxygen desaturation index ≥5

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; valvular heart surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heart Diseases; Sleep Apnea Syndromes; Acute Kidney Injury; Heart Valve Diseases
• Other Study ID Numbers: 4-2018-1017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No