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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04285359
Enrollment
514
Registered
2020-02-26
Start date
2020-10-28
Completion date
2021-04-01
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy, Hyperglycemia, Infection Post Op

Brief summary

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.

Interventions

PROCEDUREIntracranial Interventions

Neurosurgical elective intracranial interventions: supra- and infratentorial craniotomies, transnasal endoscopic interventions.

Sponsors

Burdenko Neurosurgery Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Infection rate7 days after surgeryProportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.

Secondary

MeasureTime frameDescription
Glucose levelTwice intraoperatively: before incision and at the end of surgeryIntraoperative glucose level in whole blood
History of steroids usagePreoperativelyDosages and regimen of dexamethasone in the perioperative period
Insulin dosageIntraoperativelyIntraoperative dose of insulin
Antibiotic prophylaxisPreoperativelyAntibiotic usage for prevention of postop infection: type and dosage
Duration of stay in ICU and hospital30 daysLength of stay in ICU (in hours) and in hospital (in days) after surgical intervention
Treatment outcome30 daysOutcome at the moment of discharge (improved,unchanged, worsened, death)
ComplicationsIntraoperativelyPerioperative complications (episodes of hemodynamic instability, blood loss, etc.)

Countries

Italy, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026