Patients Undergoing Craniotomy for Brain SurgeryNCT02165748
Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections
An observational study of Patients Undergoing Craniotomy for Brain Surgery, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- is to test the hypothesis that severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence of infections within the first… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients Undergoing Craniotomy for Brain Surgery
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2013to Sep 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing craniotomy for brain surgery
Who may be able to join
- Age >18
- Undergoing elective or emergency craniototmy
Who cannot join
- Age <18
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of ROme "La Sapienza"
Rome, 00161
Federico Bilotta, Md, PhD, 00393393370822, bilotta@tiscali.it
Federico Bilotta, Md, PhD
About this study
Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- is to test the hypothesis that severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence of infections within the first postoperative week (pneumonia, blood stream, urinary, surgical site/wound and cerebral infections)(NCT01923571).
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy
Measured: 7 days
Secondary outcomes (1)
survival during the study period
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2014 (estimated)
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 Patients Undergoing Craniotomy for Brain SurgeryStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Bilotta, University of Roma La Sapienza
- Investigators
- Federico Bilotta, MD, PhD, Principal investigator, Department of Anesthesiology, University of ROme "La Sapienza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165748
- Sponsor's protocol ID
- IntraopHypegl&Infections
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
Publications
Gruenbaum SE, Toscani L, Fomberstein KM, Ruskin KJ, Dai F, Qeva E, Rosa G, Meng L, Bilotta F. Severe Intraoperative Hyperglycemia Is Independently Associated With Postoperative Composite Infection After Craniotomy: An Observational Study. Anesth Analg. 2017 Aug;125(2):556-561. doi: 10.1213/ANE.0000000000001946.
PubMed 28181933
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections
- ClinicalTrials.gov ID
- NCT02165748
- Acronym / sponsor ID
- IntraopHypegl&Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- 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.
Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- is to test the hypothesis that severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence of infections within the first postoperative week (pneumonia, blood stream, urinary, surgical site/wound and cerebral infections)(NCT01923571).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing craniotomy for brain surgery
Key inclusion criteria (2 listed)
- Age >18
- Undergoing elective or emergency craniototmy
Key exclusion criteria (1 listed)
- Age <18
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
Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy
Time frame: 7 days
1 secondary outcome
survival during the study period
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Derived from this study: PubMed 28181933Gruenbaum SE, Toscani L, Fomberstein KM, Ruskin KJ, Dai F, Qeva E, Rosa G, Meng L, Bilotta F. Severe Intraoperative Hyperglycemia Is Independently Associated With Postoperative Composite Infection After Craniotomy: An Observational Study. Anesth Analg. 2017 Aug;125(2):556-561. doi: 10.1213/ANE.0000000000001946.
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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.
Federico Bilotta, MD, PhD principal investigator
Department of Anesthesiology, University of ROme "La Sapienza"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Craniotomy for Brain Surgery, run by University of Roma La Sapienza at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Bilotta, Md, PhD (0039 339 33 708 22, bilotta@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy (time frame: 7 days). 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 NCT02165748, 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 17 Jun 2014.