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

NCT04285359 | Completed

• 1 other identifier: PPN-2020-02-06
• Study Type: observational
• Target: 514
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Antibiotic prophylaxis

  Preoperatively

• Glucose level

  Twice intraoperatively: before incision and at the end of surgery

• History of steroids usage

  Preoperatively

• Insulin dosage

  Intraoperatively

• Complications

  Intraoperatively

Interventions

Intracranial Interventions PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Burdenko Neurosurgery Institute: lead

Study Sites (2)

Sapienza University of Rome

Roma, Italy

Location

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

Moscow, 125047, Russia

Location

Related Publications (1)

• 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.

  PMID: 35051950 DERIVED

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexander Kulikov

  Burdenko National Medical Research Center of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 26, 2020
• Study Start: October 28, 2020
• Primary Completion: March 15, 2021
• Study Completion: April 1, 2021
• Last Updated: April 30, 2021

Record last verified: 2020-10

Locations

IT (1); RU (1)