Hyperglycemia in Neurosurgery

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236751
• Other study ID #: H-41050
• Status: Completed
• Start date: May 24, 2021
• Est. completion date: May 13, 2023

Study information

• Verified date: September 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 13, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Infections
• Postoperative Infection

Locations

Country	Name	City	State
Italy	Sapienza University	Rome
Russian Federation	Burdenko Neurosurgery Institute	Moscow
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	Burdenko Neurosurgery Institute, University of Roma La Sapienza

Countries where clinical trial is conducted

United States,  Italy,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative infection	Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period	7 days after surgery
Secondary	Antibiotic prophylaxis scheme	Types of antibiotics administered preoperatively abstracted from electronic medical records.	Preoperatively
Secondary	Intraoperative glucose level in whole blood	Twice intraoperatively abstracted from electronic medical records	before incision and at the end of surgery
Secondary	Intraoperative dose of insulin	Abstracted from electronic medical records	During surgical procedure
Secondary	Dosages and regimen of dexamethasone in the perioperative period	Abstracted from electronic medical records	preoperative clinic visit to within 7 days of surgery
Secondary	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
Secondary	Duration of stay in ICU in hours	Abstracted from electronic medical records	30 days
Secondary	Duration of stay in hospital in days	Abstracted from electronic medical records	30 days