Hyperglycemia in Neurosurgery

Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Postoperative Infection

Detailed Description

This is a multisite [3 locations] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice.

The following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen.

The patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records.

The investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Sapienza University
• Russian Federation
  • Moscow, Russian Federation
    • Burdenko Neurosurgery Institute
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative infection	Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic prophylaxis scheme	Types of antibiotics administered preoperatively abstracted from electronic medical records.	Preoperatively
Intraoperative glucose level in whole blood	Twice intraoperatively abstracted from electronic medical records	before incision and at the end of surgery
Intraoperative dose of insulin	Abstracted from electronic medical records	During surgical procedure
Dosages and regimen of dexamethasone in the perioperative period	Abstracted from electronic medical records	preoperative clinic visit to within 7 days of surgery
Perioperative complications	Perioperative complications (such as episodes of hemodynamic instability, blood loss) abstracted from electronic medical records	preoperative clinic visit to within 7 days of surgery
Duration of stay in ICU in hours	Abstracted from electronic medical records	30 days
Duration of stay in hospital in days	Abstracted from electronic medical records	30 days

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: University of Roma La Sapienza; Burdenko Neurosurgery Institute
• Investigators: Principal Investigator: Robert J Canelli, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): May 13, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative infection; Intraoperative hyperglycemia; Neurosurgical patient; Open surgical intracranial intervention; Endoscopic intracranial intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Infections
• Other Study ID Numbers: H-41050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No