NCT06435416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
983

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

May 24, 2024

Last Update Submit

October 24, 2024

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)

Outcome Measures

Primary Outcomes (1)

  • one-year mortality

    1 year after surgery

    one-year mortality after surgery

Secondary Outcomes (1)

  • Overall mortality

    Up to the last follow-up

Study Arms (2)

PNI trajectory group 1

Other: No intervention

PNI trajectory group 2

Other: No intervention

Interventions

No interventionOTHER

No intervention

PNI trajectory group 1PNI trajectory group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing off-pump coronary artery bypass surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severnace Hospital

Seoul, GangnamGu, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 30, 2024

Study Start

July 12, 2023

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations

KR(1)