Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery

Clinical Outcome Clinical Trial

Official title:

Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05373836
• Other study ID #: PNI_Brain tumor
• Status: Not yet recruiting
• Start date: December 12, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Youn Joung Cho, MD, PhD
• Phone: +82220722467
• Email: mingming7[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are several predictors of clinical outcome in patients undergoing brain tumor surgery. Among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. However, there are lack of consistent results on predictability of nutritional index and clinical outcome in patients undergoing brain tumor surgery.

Description:

In this retrospective study, we evaluated the relationship between prognostic nutritional index, which was calculated from laboratory parameters, and clinical outcome including mortality in patients undergoing brain tumor surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea

Exclusion Criteria:

• Lack of results of laboratory parameters, such as serum albumin, lymphocyte count, cholesterol
• Lack of data on clinical outcome, including mortality, acute kidney injury, renal replacement therapy, length of hospital stay, and other major adverse outcome

Related Conditions & MeSH terms

• Brain Neoplasms
• Clinical Outcome

Intervention

Diagnostic Test:
• prognostic nutritional index calculated from laboratory parameters
Calculated nutritional index using laboratory results of serum albumin, lymphocyte count, and cholesterol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictability of prognostic nutritional index for mortality after brain tumor surgery	Odds ratio of prognostic nutritional index for postoperative mortality	From date of surgery until the date of death from any cause, whichever came first, assessed up to 50 years
Secondary	predictability of prognostic nutritional index for acute kidney injury after brain tumor surgery	Odds ratio of prognostic nutritional index for postoperative acute kidney injury	From date of surgery until the date of acute kidney injury from any cause, whichever came first, assessed up to 50 years
Secondary	predictability of prognostic nutritional index for renal replacement therapy after brain tumor surgery	Odds ratio of prognostic nutritional index for postoperative renal replacement therapy	From date of surgery until the date of renal replacement therapy from any cause, whichever came first, assessed up to 50 years
Secondary	relationship of prognostic nutritional index for length of hospital stay after brain tumor surgery	Odds ratio of prognostic nutritional index for length of hospital stay	From date of surgery until the date of hospital discharge