Valvular Heart DiseaseNCT04080219
The Impact of Sleep-disordered Breathing on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery
An observational study of Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 414 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2018to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing valvular heart surgery
Who may be able to join
- Adult patient aged more than 20 years
- Patients undergoing valvular heart surgery.
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Sarah Soh, MD, 82-10-5108-0118, yeonchoo@yuhs.ac
About this study
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
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
- Keywords
- valvular heart surgery, cardiopulmonary bypass
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Patients with Oxygen desaturation index <5 | |
| Sleep-disordered breathing | Patients with Oxygen desaturation index ≥5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 7 days
Secondary outcomes (3)
Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)
Urinary NGAL measurement by ELISA after anesthetic induction
Measured: 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
Measured: 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
Measured: Post-CPB 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start19 Dec 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080219
- Sponsor's protocol ID
- 4-2018-1017
- Status last verified
- Jan 2020
- First submitted
- 1 Sep 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04080219
- Acronym / sponsor ID
- 4-2018-1017
- Conditions
- Valvular Heart Disease
- Keywords
- valvular heart surgery, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Patients with Oxygen desaturation index <5 |
| Sleep-disordered breathing | – | –Patients with Oxygen desaturation index ≥5 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing valvular heart surgery
Key inclusion criteria (2 listed)
- Adult patient aged more than 20 years
- Patients undergoing valvular heart surgery.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative acute kidney injury
Time frame: 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.
3 secondary outcomes
Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)
Time frame: 15 minutes after anesthetic induction
Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)
Time frame: Post-CPB 6hours
Urinary NGAL(Neutrophil gelatinase-associated lipocalin) by ELISA(enzyme-linked immunosorbent assay)
Time frame: Post-CPB 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Valvular Heart Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.