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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04307732

Collaborator

(none)

2,000

Enrollment

Location

11.5

Anticipated Duration (Months)

173.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing Valvular Heart Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 15, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Outcome Measures

Primary Outcome Measures

postoperative mortality according to peroperative nutritional status [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 [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.

Secondary Outcome Measures

predictive discrimination ability for mortality between PNI, GNRI, and CONUT [1 year after surgery]
The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.
predictive discrimination ability for mortality between PNI, GNRI, and CONUT [2 year after surgery]
The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04307732

Other Study ID Numbers:

4-2020-0024

First Posted:

Mar 13, 2020

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 14, 2020