Skip to main content
OpenTrials
Completed

NCT Number: NCT04285359

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sapienza University of Rome, Roma, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracranial Interventions

Procedure

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

Primary outcomes

  1. Infection rate

    Time frame: 7 days after surgery

    Proportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.

Secondary outcomes

  1. Antibiotic prophylaxis

    Time frame: Preoperatively

    Antibiotic usage for prevention of postop infection: type and dosage

  2. Glucose level

    Time frame: Twice intraoperatively: before incision and at the end of surgery

    Intraoperative glucose level in whole blood

  3. History of steroids usage

    Time frame: Preoperatively

    Dosages and regimen of dexamethasone in the perioperative period

  4. Insulin dosage

    Time frame: Intraoperatively

    Intraoperative dose of insulin

  5. Complications

    Time frame: Intraoperatively

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

  6. Duration of stay in ICU and hospital

    Time frame: 30 days

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

  7. Treatment outcome

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Burdenko Neurosurgery Institute

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2020
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.