Patients Undergoing Valvular Heart SurgeryNCT04307732
Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery
An observational study of Patients Undergoing Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Valvular Heart Surgery
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2020to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Terticary care hospital
Who may be able to join
- Patients who underwent valvular heart surgery from January 2013 to February 2018
Who cannot join
- Patients younger than 18 years
- Patients undergoing combined congenital heart surgery
- Patients undergoing transcatheter valve replacement
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
Jin Sun Cho, chjs0214@yuhs.ac
About this study
The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score. The primary outcome was the association between preoperative nutritional status evaluated by PNI, GNRI, and CONUT score and postoperative mortality. The predictive discrimination ability for mortality between PNI, GNRI, and CONUT were compared. Risk factors for mortality were identified.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative mortality according to peroperative nutritional status
The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated.
Measured: 1 year after surgery
postoperative mortality according to peroperative nutritional status
The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated.
Measured: 2 year after surgery
Secondary outcomes (2)
predictive discrimination ability for mortality between PNI, GNRI, and CONUT
The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.
Measured: 1 year after surgery
predictive discrimination ability for mortality between PNI, GNRI, and CONUT
The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.
Measured: 2 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start15 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Valvular Heart SurgeryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 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
- NCT04307732
- Sponsor's protocol ID
- 4-2020-0024
- Status last verified
- Oct 2020
- First submitted
- 10 Mar 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho JS, Shim JK, Kim KS, Lee S, Kwak YL. Impact of preoperative nutritional scores on 1-year postoperative mortality in patients undergoing valvular heart surgery. J Thorac Cardiovasc Surg. 2022 Oct;164(4):1140-1149.e3. doi: 10.1016/j.jtcvs.2020.12.099. Epub 2021 Jan 5.
PubMed 33551075
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT04307732
- Acronym / sponsor ID
- 4-2020-0024
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score. The primary outcome was the association between preoperative nutritional status evaluated by PNI, GNRI, and CONUT score and postoperative mortality. The predictive discrimination ability for mortality between PNI, GNRI, and CONUT were compared. Risk factors for mortality were identified.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Terticary care hospital
Key inclusion criteria (1 listed)
- Patients who underwent valvular heart surgery from January 2013 to February 2018
Key exclusion criteria (3 listed)
- Patients younger than 18 years
- Patients undergoing combined congenital heart surgery
- Patients undergoing transcatheter valve replacement
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 mortality according to peroperative nutritional status
Time frame: 1 year after surgery
The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated.
postoperative mortality according to peroperative nutritional status
Time frame: 2 year after surgery
The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated.
2 secondary outcomes
predictive discrimination ability for mortality between PNI, GNRI, and CONUT
Time frame: 1 year after surgery
predictive discrimination ability for mortality between PNI, GNRI, and CONUT
Time frame: 2 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 33551075Cho JS, Shim JK, Kim KS, Lee S, Kwak YL. Impact of preoperative nutritional scores on 1-year postoperative mortality in patients undergoing valvular heart surgery. J Thorac Cardiovasc Surg. 2022 Oct;164(4):1140-1149.e3. doi: 10.1016/j.jtcvs.2020.12.099. Epub 2021 Jan 5.
- Individual participant dataSharing planned: No
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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.
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 Patients Undergoing Valvular Heart Surgery, 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 1 inclusion and 3 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 14 Oct 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?
Contact Jin Sun Cho (82-2-2228-4433, chjs0214@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative mortality according to peroperative nutritional status (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04307732, which also lists 1 linked publication.
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 14 Oct 2020.