Clinical trial NCT04285359: Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
Official title: Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Craniotomy
Infection Post Op
Lead sponsor: Burdenko Neurosurgery Institute
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (\>18 years) scheduled for elective intracranial intervention.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Infection rate
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Antibiotic prophylaxis
timeFrame: Preoperatively
measure: Glucose level
timeFrame: Twice intraoperatively: before incision and at the end of surgery
measure: History of steroids usage
timeFrame: Preoperatively
measure: Insulin dosage
timeFrame: Intraoperatively
measure: Complications
timeFrame: Intraoperatively
measure: Duration of stay in ICU and hospital
timeFrame: 30 days
measure: Treatment outcome
timeFrame: 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
Study officials:
affiliation: Burdenko National Medical Research Center of Neurosurgery
name: Alexander Kulikov
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.