Clinical trial NCT05236751: Hyperglycemia in Neurosurgery
Official title: Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Postoperative Infection
Keywords: Intraoperative hyperglycemia
Postoperative infection
Neurosurgical patient
Open surgical intracranial intervention
Endoscopic intracranial intervention
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: Burdenko Neurosurgery Institute
First posted: 2022-02-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative infection
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Antibiotic prophylaxis scheme
timeFrame: Preoperatively
measure: Intraoperative glucose level in whole blood
timeFrame: before incision and at the end of surgery
measure: Intraoperative dose of insulin
timeFrame: During surgical procedure
measure: Dosages and regimen of dexamethasone in the perioperative period
timeFrame: preoperative clinic visit to within 7 days of surgery
measure: Perioperative complications
timeFrame: preoperative clinic visit to within 7 days of surgery
measure: Duration of stay in ICU in hours
timeFrame: 30 days
measure: Duration of stay in hospital in days
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Rome
country: Italy
facility: Sapienza University
city: Moscow
country: Russian Federation
facility: Burdenko Neurosurgery Institute
Study officials:
affiliation: Boston Medical Center
name: Robert J Canelli, MD
role: PRINCIPAL_INVESTIGATOR
References: