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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285359
• Other study ID #: PPN-2020-02-06
• Status: Completed
• Start date: October 28, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2020
• Source: Burdenko Neurosurgery Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: April 1, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Craniotomy
• Hyperglycemia
• Infection
• Infection Post Op

Intervention

Procedure:
• Intracranial Interventions
Neurosurgical elective intracranial interventions: supra- and infratentorial craniotomies, transnasal endoscopic interventions.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Burdenko Neurosurgery Institute

Countries where clinical trial is conducted

Italy,  Russian Federation, 

Outcome

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