HyperglycemiaNCT05236751
Hyperglycemia in Neurosurgery
An observational study of Hyperglycemia and Postoperative Infection, run by Boston Medical Center at 3 sites in 3 countries.
Trial summary
Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postoperative Infection
- How many people
- 52 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 24 May 2021to 13 May 2023
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least 1 day post-procedure.
Who may be able to join
- Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention
- General anesthesia
- Hospital stay of at least 1 day post-procedure
Who cannot join
- Diagnosis of infection (local or systemic) in preoperative period
- Emergency procedures
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.
Read the detailed description
This is a multisite [3 locations] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice.
The following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen.
The patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records.
The investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data.
- Conditions
- Hyperglycemia, Postoperative Infection
- Keywords
- Intraoperative hyperglycemia, Postoperative infection, Neurosurgical patient, Open surgical intracranial intervention, Endoscopic intracranial intervention
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective intracranial intervention patients | Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least one day post-procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infection
Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period
Measured: 7 days after surgery
Secondary outcomes (7)
Antibiotic prophylaxis scheme
Types of antibiotics administered preoperatively abstracted from electronic medical records.
Measured: Preoperatively
Intraoperative glucose level in whole blood
Twice intraoperatively abstracted from electronic medical records
Measured: before incision and at the end of surgery
Intraoperative dose of insulin
Abstracted from electronic medical records
Measured: During surgical procedure
Dosages and regimen of dexamethasone in the perioperative period
Abstracted from electronic medical records
Measured: preoperative clinic visit to within 7 days of surgery
Perioperative complications
Perioperative complications (such as episodes of hemodynamic instability, blood loss) abstracted from electronic medical records
Measured: preoperative clinic visit to within 7 days of surgery
Duration of stay in ICU in hours
Abstracted from electronic medical records
Measured: 30 days
Duration of stay in hospital in days
Abstracted from electronic medical records
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 posted11 Feb 2022
- Study start24 May 2021
- Primary completion11 Apr 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, Burdenko Neurosurgery Institute
- Responsible party
- Sponsor
- Investigators
- Robert J Canelli, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236751
- Sponsor's protocol ID
- H-41050
- Status last verified
- Sep 2023
- First submitted
- 2 Feb 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. 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
- NCT05236751
- Acronym / sponsor ID
- H-41050
- Conditions
- Hyperglycemia, Postoperative Infection
- Keywords
- Intraoperative hyperglycemia, Postoperative infection, Neurosurgical patient, Open surgical intracranial intervention, Endoscopic intracranial intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, Burdenko Neurosurgery Institute
- Study start
- 24 May 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 11 Feb 2022 (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.
Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.
Detailed description
This is a multisite [3 locations] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice.
The following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen.
The patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records.
The investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective intracranial intervention patients | – | –Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least one day post-procedure. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-89 years at the time of surgery) scheduled for elective intracranial (open surgical or endoscopic) intervention and require general anesthesia and a hospital stay of at least 1 day post-procedure.
Key inclusion criteria (3 listed)
- Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention
- General anesthesia
- Hospital stay of at least 1 day post-procedure
Key exclusion criteria (2 listed)
- Diagnosis of infection (local or systemic) in preoperative period
- Emergency procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative infection
Time frame: 7 days after surgery
Proportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period
7 secondary outcomes
Antibiotic prophylaxis scheme
Time frame: Preoperatively
Intraoperative glucose level in whole blood
Time frame: before incision and at the end of surgery
Intraoperative dose of insulin
Time frame: During surgical procedure
Dosages and regimen of dexamethasone in the perioperative period
Time frame: preoperative clinic visit to within 7 days of surgery
Perioperative complications
Time frame: preoperative clinic visit to within 7 days of surgery
Duration of stay in ICU in hours
Time frame: 30 days
Duration of stay in hospital in days
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 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Robert J Canelli, MD principal investigator
Boston Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Postoperative Infection, run by Boston Medical Center at 3 sites in 3 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 3 inclusion and 2 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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?
Postoperative infection (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?
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 28 Sep 2023.