Hyperglycemia in Neurosurgery

Completed

• Conditions: Postoperative Infection; Hyperglycemia

• Registration Number: NCT05236751
• Lead Sponsor: Boston Medical Center

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.

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 Timeline

• Study Start: 2021-05-24
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Primary Completion: 2023-04-11
• Study Completion: 2023-05-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-24
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Sapienza University; 🇮🇹 Rome, Italy

Burdenko Neurosurgery Institute; 🇷🇺 Moscow, Russian Federation

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States