NCT04080219

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
414

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

September 1, 2019

Last Update Submit

January 28, 2020

Conditions

Valvular Heart Disease

Keywords

valvular heart surgerycardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)

    15 minutes after anesthetic induction

  • Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)

    Post-CPB 6hours

  • Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)

    Post-CPB 24hours

Study Arms (2)

Normal

Patients with Oxygen desaturation index \<5

Sleep-disordered breathing

Patients with Oxygen desaturation index ≥5

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing valvular heart surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators measure the urinary NGAL.

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2019

First Posted

September 6, 2019

Study Start

December 19, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)