Hyperglycemia in Neurosurgery

NCT05236751 | Completed

• 1 other identifier: H-41050
• Study Type: observational
• Target: 52
• Locations: 3 countries
• Sites: 3

Brief Summary

Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.

Conditions

Hyperglycemia; Postoperative Infection

Keywords

Intraoperative hyperglycemia; Postoperative infection; Neurosurgical patient; Open surgical intracranial intervention; Endoscopic intracranial intervention

Outcome Measures

Primary Outcomes (1)

• Postoperative infection

  Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period

  7 days after surgery

Secondary Outcomes (7)

• Antibiotic prophylaxis scheme

  Preoperatively

• Intraoperative glucose level in whole blood

  before incision and at the end of surgery

• Intraoperative dose of insulin

  During surgical procedure

• Dosages and regimen of dexamethasone in the perioperative period

  preoperative clinic visit to within 7 days of surgery

• Perioperative complications

  preoperative clinic visit to within 7 days of surgery

Study Arms (1)

Elective intracranial intervention patients

Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least one day post-procedure.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least 1 day post-procedure.

You may qualify if:

• Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention
• General anesthesia
• Hospital stay of at least 1 day post-procedure

You may not qualify if:

• Diagnosis of infection (local or systemic) in preoperative period
• Emergency procedures

Sponsors & Collaborators

• Boston Medical Center: lead
• University of Roma La Sapienza: collaborator
• Burdenko Neurosurgery Institute: collaborator

Study Sites (3)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Sapienza University

Rome, Italy

Location

Burdenko Neurosurgery Institute

Moscow, Russia

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert J Canelli, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: May 24, 2021
• Primary Completion: April 11, 2023
• Study Completion: May 13, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IT (1); US (1); RU (1)