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

NCT ID: NCT04285359

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 514 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2021-04-01

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.

Conditions

Hyperglycemia; Craniotomy; Infection Post Op

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Intracranial Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burdenko Neurosurgery Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Kulikov

Role: PRINCIPAL_INVESTIGATOR

Burdenko National Medical Research Center of Neurosurgery

Locations

Sapienza University of Rome

Roma, , Italy

Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation

Moscow, , Russia

Countries

Italy; Russia

References

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.

Reference Type: DERIVED

PMID: 35051950 (View on PubMed)

Other Identifiers

PPN-2020-02-06

Identifier Type: -

Identifier Source: org_study_id