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NCT Number: NCT05236751

Hyperglycemia in Neurosurgery

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.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postoperative Infection

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sapienza University, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative infection

    Time frame: 7 days after surgery

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

Secondary outcomes

  1. Antibiotic prophylaxis scheme

    Time frame: Preoperatively

    Types of antibiotics administered preoperatively abstracted from electronic medical records.

  2. Intraoperative glucose level in whole blood

    Time frame: before incision and at the end of surgery

    Twice intraoperatively abstracted from electronic medical records

  3. Intraoperative dose of insulin

    Time frame: During surgical procedure

    Abstracted from electronic medical records

  4. Dosages and regimen of dexamethasone in the perioperative period

    Time frame: preoperative clinic visit to within 7 days of surgery

    Abstracted from electronic medical records

  5. Perioperative complications

    Time frame: preoperative clinic visit to within 7 days of surgery

    Perioperative complications (such as episodes of hemodynamic instability, blood loss) abstracted from electronic medical records

  6. Duration of stay in ICU in hours

    Time frame: 30 days

    Abstracted from electronic medical records

  7. Duration of stay in hospital in days

    Time frame: 30 days

    Abstracted from electronic medical records

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Burdenko Neurosurgery Institute
  • University of Roma La Sapienza

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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