Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Brain Tumors Clinical Trial

Official title:

Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530749
• Other study ID #: 14-0579
• Status: Completed
• Start date: April 2014
• Est. completion date: March 2019

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Description:

Preoperative risk assessment is important, but inexact, in older patients because physiologic reserves are difficult to measure. This also makes an important difference related to brain tumor patients, who may be burdened with systemic disease, alterations in cognition, or affected by other comorbidities. When assessing quality of life for brain tumor patients, having a better predictor of postsurgical outcome would be beneficial in appropriately counseling these patients. Frailty is thought to estimate physiologic reserves, and its use has been found to predict postoperative complications, length of stay, and discharge to a skilled or assisted-living facility in neurosurgical patients. Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• Ambulatory (able to walk)

• Scheduled for neurosurgical resection of brain tumor

Exclusion Criteria:

• Parkinson disease

• Previous stroke

• Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Frailty

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a Complication risk	Number of patients with a complication risk based on a Hopkins Frailty Score (HFS).	30 days
Secondary	Length of stay based on a Hopkins Frailty Score (HFS).	Number of patients with a prolonged length of stay based on a Hopkins Frailty Score (HFS).	30 days
Secondary	Number of patients Discharge to a skilled or assisted-living facility	Number of patients discharged to a skilled or assisted-living facility based on a Hopkins Frailty Score (HFS).	30 days