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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05373836
• Collaborator: (none)
• Enrollment: 5,000
• Anticipated Duration (Months): 7.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Outcome	Diagnostic Test: prognostic nutritional index calculated from laboratory parameters

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery
• Anticipated Study Start Date: May 12, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
brain tumor surgery adult patients undergoing brain tumor surgery	Diagnostic Test: prognostic nutritional index calculated from laboratory parameters; Calculated nutritional index using laboratory results of serum albumin, lymphocyte count, and cholesterol

Outcome Measures

Primary Outcome Measures

1. predictability of prognostic nutritional index for mortality after brain tumor surgery [From date of surgery until the date of death from any cause, whichever came first, assessed up to 50 years]

   Odds ratio of prognostic nutritional index for postoperative mortality

Secondary Outcome Measures

1. predictability of prognostic nutritional index for acute kidney injury after brain tumor surgery [From date of surgery until the date of acute kidney injury from any cause, whichever came first, assessed up to 50 years]

   Odds ratio of prognostic nutritional index for postoperative acute kidney injury

2. predictability of prognostic nutritional index for renal replacement therapy after brain tumor surgery [From date of surgery until the date of renal replacement therapy from any cause, whichever came first, assessed up to 50 years]

   Odds ratio of prognostic nutritional index for postoperative renal replacement therapy

3. relationship of prognostic nutritional index for length of hospital stay after brain tumor surgery [From date of surgery until the date of hospital discharge]

   Odds ratio of prognostic nutritional index for length of hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Youn Joung Cho, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Youn Joung Cho, MD, PhD, Clinical Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT05373836
• Other Study ID Numbers: PNI_Brain tumor
• First Posted: May 13, 2022
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Youn Joung Cho, MD, PhD, Clinical Associate Professor, Seoul National University Hospital: nutritional index; brain tumor surgery; mortality
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of May 13, 2022