HyperglycemiaNCT04285359
Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
An observational study of Hyperglycemia and Craniotomy, run by Burdenko Neurosurgery Institute at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Craniotomy, Infection Post Op
- What is being tested?
- Intracranial Interventions
- Type of treatment
- Surgery or procedure
- How many people
- 514 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Oct 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>18 years) scheduled for elective intracranial intervention.
Who may be able to join
- Adult patients (>18 years) scheduled for elective intracranial (open or endoscopic) intervention.
Who cannot join
- Diagnosis of infection (local or systemic) in preoperative period; urgent intervention.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Russia1 site
Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
Moscow, 125047
About this study
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
- Being tested
- Intracranial Interventions
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial InterventionsProcedure or surgery
Neurosurgical elective intracranial interventions: supra- and infratentorial craniotomies, transnasal endoscopic interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate
Proportion of patients diagnosed with infection (wound, pulmonary, urological, blood etc.) in the postoperative period according to CDC.
Measured: 7 days after surgery
Secondary outcomes (7)
Antibiotic prophylaxis
Antibiotic usage for prevention of postop infection: type and dosage
Measured: Preoperatively
Glucose level
Intraoperative glucose level in whole blood
Measured: Twice intraoperatively: before incision and at the end of surgery
History of steroids usage
Dosages and regimen of dexamethasone in the perioperative period
Measured: Preoperatively
Insulin dosage
Intraoperative dose of insulin
Measured: Intraoperatively
Complications
Perioperative complications (episodes of hemodynamic instability, blood loss, etc.)
Measured: Intraoperatively
Duration of stay in ICU and hospital
Length of stay in ICU (in hours) and in hospital (in days) after surgical intervention
Measured: 30 days
Treatment outcome
Outcome at the moment of discharge (improved,unchanged, worsened, death)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start28 Oct 2020
- Primary completion15 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdenko Neurosurgery Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Kulikov, Principal investigator, Burdenko National Medical Research Center of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285359
- Sponsor's protocol ID
- PPN-2020-02-06
- Status last verified
- Oct 2020
- First submitted
- 22 Feb 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35051950
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
- ClinicalTrials.gov ID
- NCT04285359
- Acronym / sponsor ID
- PPN-2020-02-06
- Conditions
- Hyperglycemia, Craniotomy, Infection Post Op
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Burdenko Neurosurgery InstituteUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years) scheduled for elective intracranial intervention.
Key inclusion criteria (1 listed)
- Adult patients (>18 years) scheduled for elective intracranial (open or endoscopic) intervention.
Key exclusion criteria (1 listed)
- Diagnosis of infection (local or systemic) in preoperative period; urgent intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial InterventionsNeurosurgical elective intracranial interventions: supra- and infratentorial craniotomies, transnasal endoscopic interventions. | Procedure or surgery | – |
Primary outcome
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.
7 secondary outcomes
Antibiotic prophylaxis
Time frame: Preoperatively
Glucose level
Time frame: Twice intraoperatively: before incision and at the end of surgery
History of steroids usage
Time frame: Preoperatively
Insulin dosage
Time frame: Intraoperatively
Complications
Time frame: Intraoperatively
Duration of stay in ICU and hospital
Time frame: 30 days
Treatment outcome
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 35051950Kulikov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Kulikov principal investigator
Burdenko National Medical Research Center of Neurosurgery
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Craniotomy, run by Burdenko Neurosurgery Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.