## Protocol Section
### Identification Module
**NCT ID:** NCT06435416

**Brief Title:** Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery

**Official Title:** Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery

#### Organization Study ID Info
**ID:** 3-2023-0184
#### Organization
**Class:** OTHER
**Full Name:** Gangnam Severance Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-07-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gangnam Severance Hospital

#### Responsible Party

**Investigator Affiliation:** Gangnam Severance Hospital

**Investigator Full Name:** Myung Il Bae

**Investigator Title:** Clinical Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.

### Conditions Module

**Conditions:**

- Patients Undergoing Off-pump Coronary Artery by Pass Surgery

**Keywords:**

- Prognostic Nutritional Index (PNI)

- Off-pump coronary artery bypass (OPCAB),

- Coronary artery bypass graft surgery (CABG)

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 983

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: No intervention

**Label:** PNI trajectory group 1

#### Arm Group 2

**Intervention Names:**

- Other: No intervention

**Label:** PNI trajectory group 2

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PNI trajectory group 1

- PNI trajectory group 2

**Description:** No intervention

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 1 year after surgery

**Measure:** one-year mortality

**Time Frame:** one-year mortality after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

• Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery

Exclusion Criteria:

* Patients without PNI value between 1 and 3 days after surgery
* Patients without PNI value between 20 and 60 days after surgery

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing off-pump coronary artery bypass surgery

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bmi87@yuhs.ac

**Name:** Myung Il Bae

**Phone:** 82-2-2019-6611

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** bmi87@yuhs.ac

- **Name:** Myung Il Bae

- **Phone:** 82-2-2019-6611

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Gangnam Severnace Hospital

**State:** GangnamGu

**Status:** RECRUITING

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
