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Status unknownNCT04307732Updated Oct 14, 2020

Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery

An observational study in Patients Undergoing Valvular Heart Surgery, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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) 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.

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Conditions studied

  • Patients Undergoing Valvular Heart Surgery
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Terticary care hospital

Inclusion criteria

  • Patients who underwent valvular heart surgery from January 2013 to February 2018

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients undergoing combined congenital heart surgery
  • Patients undergoing transcatheter valve replacement
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year after surgery

  2. 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.

    Time frame: 2 year after surgery

Secondary outcomes

  1. predictive discrimination ability for mortality between PNI, GNRI, and CONUT

    The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.

    Time frame: 1 year after surgery

  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.

    Time frame: 2 year after surgery

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Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    Seoul, Korea, Republic of
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04307732
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Mar 13, 2020
Start date
Mar 15, 2020
Primary completion
Mar 2021 (estimated)
Completion
Mar 2021 (estimated)
Last update
Oct 14, 2020

Study contacts

Jin Sun Cho
Contact
chjs0214@yuhs.ac
82-2-2228-4433

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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