Hyperglycemia in Neurosurgery

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05236751
Study type	Observational
Source	Boston Medical Center
Contact
Status	Completed
Phase
Start date	May 24, 2021
Completion date	May 13, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01267448` - Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia	Phase 4
Recruiting	`NCT03775733` - Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia	N/A
Completed	`NCT03482154` - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Active, not recruiting	`NCT05477368` - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes	N/A
Completed	`NCT03675360` - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial	N/A
Completed	`NCT00535600` - Effects of Bariatric Surgery on Insulin
Not yet recruiting	`NCT06159543` - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes	N/A
Recruiting	`NCT02885909` - Inpatient Blood Glucose Control in Taichung Veterans General Hospital	Phase 4
Recruiting	`NCT02885922` - The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients
Completed	`NCT02012465` - Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients	Early Phase 1
Withdrawn	`NCT01488383` - Effect of Stevioside in Postpandrial Glucose in Healthy Adults	N/A
Completed	`NCT01805414` - Breakfast Nutrition and Inpatient Glycemia	N/A
Completed	`NCT01803568` - Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU	N/A
Completed	`NCT01810952` - The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients	Phase 4
Active, not recruiting	`NCT01247714` - Clinical Evaluation of a Specific Enteral Diet for Diabetics	N/A
Not yet recruiting	`NCT00846144` - The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients	N/A
Completed	`NCT00996099` - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients	N/A
Recruiting	`NCT00654797` - Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2	Phase 2
Completed	`NCT00468494` - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?	N/A
Completed	`NCT00394407` - Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes	Phase 4