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

Severe intraoperative hyperglycemia (SIH) is recognized as one of the important risk factors for the increasing of the postoperative infections rate, which can negatively affect the final outcome of surgical treatment. Studies in recent years have shown a much higher incidence of wound infections, respiratory and urinary tract infections in patients who intraoperatively had an increase in blood glucose level (BGL) above 180 mg/dl (10 mmol/l). This problem in neurosurgery is especially important due to the high proportion of patients with acute injuries and potentially long-term need for postoperative intensive care, as well as the frequent use of drugs that increase blood glucose level (steroids) in neurooncology. Most published studies include patients from both of these groups. This study is aimed to assess the impact of severe intraoperative hyperglycemia on the incidence of infectious complications only in patients scheduled for elective intracranial interventions.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Craniotomy; Infection Post Op
• Intervention / Treatment: Procedure: Intracranial Interventions

• Study Type: Observational
• Enrollment (Actual): 514

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Sapienza University of Rome
• Russian Federation
  • Moscow, Russian Federation, 125047
    • Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients (>18 years) scheduled for elective intracranial intervention.

Description

Inclusion Criteria:

Adult patients (>18 years) scheduled for elective intracranial (open or endoscopic) intervention.

Exclusion Criteria:

Diagnosis of infection (local or systemic) in preoperative period; urgent intervention.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate	Proportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic prophylaxis	Antibiotic usage for prevention of postop infection: type and dosage	Preoperatively
Glucose level	Intraoperative glucose level in whole blood	Twice intraoperatively: before incision and at the end of surgery
History of steroids usage	Dosages and regimen of dexamethasone in the perioperative period	Preoperatively
Insulin dosage	Intraoperative dose of insulin	Intraoperatively
Complications	Perioperative complications (episodes of hemodynamic instability, blood loss, etc.)	Intraoperatively
Duration of stay in ICU and hospital	Length of stay in ICU (in hours) and in hospital (in days) after surgical intervention	30 days
Treatment outcome	Outcome at the moment of discharge (improved,unchanged, worsened, death)	30 days

Collaborators and Investigators

• Sponsor: Burdenko Neurosurgery Institute
• Investigators: Principal Investigator: Alexander Kulikov, Burdenko National Medical Research Center of Neurosurgery

Publications and helpful links

General Publications

• Kulikov A, Krovko Y, Nikitin A, Shmigelsky A, Zagidullin T, Ershova O, Gadzhieva O, Bilotta F. Severe Intraoperative Hyperglycemia and Infectious Complications After Elective Brain Neurosurgical Procedures: Prospective Observational Study. Anesth Analg. 2022 Nov 1;135(5):1082-1088. doi: 10.1213/ANE.0000000000005912. Epub 2022 Jan 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2020
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (ACTUAL): February 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperglycemia; Infections; Communicable Diseases
• Other Study ID Numbers: PPN-2020-02-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No