NCT07356219

Brief Summary

Coronary artery bypass grafting (CABG) is a major cardiac surgery associated with risks of serious perioperative complications and mortality. Malnutrition and inflammation are known independent risk factors for poor outcomes in patients with coronary artery disease. This retrospective observational study evaluates the Prognostic Nutritional Index (PNI)-a simple score derived from serum albumin and lymphocyte counts-as an objective measure of nutritional and inflammatory status. The research aims to determine how well preoperative PNI and its postoperative changes can predict complications such as acute kidney injury, myocardial infarction, and sternal wound infections in patients undergoing CABG.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 11, 2026

Last Update Submit

January 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of the Prognostic Nutritional Index (PNI) in Predicting Post-CABG Complications.

    The Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) used to determine the performance of the PNI score in predicting the occurrence of major postoperative complications.

    Approximately 30 days (From surgery through the duration of the hospital/ICU stay.)

Study Arms (1)

CABG Patient Cohort.

Patients who underwent Coronary Artery Bypass Grafting surgery at Benha University Hospital over the preceding five years.

Diagnostic Test: Prognostic Nutritional Index (PNI)Diagnostic Test: Neutrophil-to-Lymphocyte Ratio (NLR)Diagnostic Test: Body Mass Index (BMI)

Interventions

Calculated using serum albumin (g/L) and total peripheral lymphocyte count.

CABG Patient Cohort.

Calculated from peripheral blood counts.

CABG Patient Cohort.
Body Mass Index (BMI)DIAGNOSTIC_TEST

Calculated from preoperative weight and height.

CABG Patient Cohort.

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients (both male and female) who underwent major coronary artery bypass grafting surgery at the Cardiothoracic Surgery Department of Benha University Hospital within a recent five-year period.

You may qualify if:

  • Patients who underwent CABG surgery.
  • Availability of a signed informed consent form before surgery.

You may not qualify if:

  • Other concurrent cardiac surgeries.
  • Presence of malignancy or systemic inflammatory disorders.
  • Active infection or autoimmune disorders.
  • Maintenance on immunosuppressants.
  • Liver disease.
  • Files with missing data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Body Mass Index

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Body Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Cardiothoracic Surgery, Faculty of Medicine, Benha University, Egypt

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 21, 2026

Study Start

November 15, 2025

Primary Completion

January 11, 2026

Study Completion

January 20, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations