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

Completed

• Conditions: Infection Post Op; Craniotomy; Hyperglycemia

• Registration Number: NCT04285359
• Lead Sponsor: Burdenko Neurosurgery Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-22
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Status Verified: 2020-10
• Study Start: 2020-10-28
• Primary Completion: 2021-03-15
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 514

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infection rate	7 days after surgery	Proportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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, Russian Federation