Preoperative Nutritional Status Scores to Predict PPC in... | NCT06340464

Studies
Preoperative Nutritional Status Scores to Predict PPC in Elderly With Cardiac Surgery

NCT06340464

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

217Actual

Phase

Not provided

Conditions

Cardiac Surgery
Elderly Patient
Postoperative Pulmonary Complication
Nutrition Scoring System

Interventions

Nutrition scoring systems

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Apr 30, 2026Actual

Completion Date

Apr 30, 2026Actual

First Submitted Date

Mar 25, 2024

First Submission Date that Met QC Criteria

Mar 25, 2024

First Posted Date

Apr 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2026

Last Update Posted Date

Jun 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Panalee Kittisopaporn, Principal investigator, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective study investigates prognostic values and compares the role of nutritional status by using GNRI, MNA-SF, PNI, and NAF in predicting post-operative pulmonary complication among elderly patients with cardiac surgery.

Detailed Description

In this prospective cohort study, 217 patients aged ≥60 years undergoing elective cardiac surgery at a tertiary university hospital were enrolled. Preoperative nutritional status was assessed using GNRI, MNA-SF, PNI, and NAF. The primary outcome was PPC occurrence during hospitalization. Predictive performance was evaluated using receiver operating characteristic (ROC) analysis, and multivariable logistic regression identified independent predictors

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

217Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
older patients		patients aged ≥60 years undergoing elective cardiac surgery	Other: Nutrition scoring systems

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrition scoring systems	Other	GNRI, MNA-SF, PNI, and NAF	older patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pulmonary complication	PPCs such as pneumonia, pulmonary embolism, ventilation longer than 24 h, pleural effusions necessitating drainage and reintubation within 72 h of extubation	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elderly patient age ≥ 60 years
Open heart surgical procedure on pump (CABG, valvular disease, combine CABG and valve surgery
Elective surgery

Exclusion Criteria:

- Emergency surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Elderly patients (aged ≥ 60 years old) who undergoing cardiac surgery in Songklanagarind hospital, Songkla, Thailand

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Panalee Kittisopaporn	Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

ethical considerations

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided