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

Sponsor
Burdenko Neurosurgery Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04285359
Collaborator
(none)
514
2
5.1
257
50.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intracranial Interventions

Study Design

Study Type:
Observational
Actual Enrollment :
514 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
Actual Study Start Date :
Oct 28, 2020
Actual Primary Completion Date :
Mar 15, 2021
Actual Study Completion Date :
Apr 1, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Antibiotic prophylaxis [Preoperatively]

    Antibiotic usage for prevention of postop infection: type and dosage

  2. Glucose level [Twice intraoperatively: before incision and at the end of surgery]

    Intraoperative glucose level in whole blood

  3. History of steroids usage [Preoperatively]

    Dosages and regimen of dexamethasone in the perioperative period

  4. Insulin dosage [Intraoperatively]

    Intraoperative dose of insulin

  5. Complications [Intraoperatively]

    Perioperative complications (episodes of hemodynamic instability, blood loss, etc.)

  6. Duration of stay in ICU and hospital [30 days]

    Length of stay in ICU (in hours) and in hospital (in days) after surgical intervention

  7. Treatment outcome [30 days]

    Outcome at the moment of discharge (improved,unchanged, worsened, death)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sapienza University of Rome Roma Italy
2 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 125047

Sponsors and Collaborators

  • Burdenko Neurosurgery Institute

Investigators

  • Principal Investigator: Alexander Kulikov, Burdenko National Medical Research Center of Neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Burdenko Neurosurgery Institute
ClinicalTrials.gov Identifier:
NCT04285359
Other Study ID Numbers:
  • PPN-2020-02-06
First Posted:
Feb 26, 2020
Last Update Posted:
Apr 30, 2021
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2021