Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections

NCT ID: NCT02165748

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Patients Undergoing Craniotomy for Brain Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \>18
* Undergoing elective or emergency craniototmy

Exclusion Criteria

* Age \<18
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Federico Bilotta

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Bilotta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University of ROme "La Sapienza"

Locations

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University of ROme "La Sapienza"

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federico Bilotta, Md, PhD

Role: CONTACT

0039 339 33 708 22

Facility Contacts

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Federico Bilotta, Md, PhD

Role: primary

00393393370822

References

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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.

Reference Type DERIVED
PMID: 28181933 (View on PubMed)

Other Identifiers

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IntraopHypegl&Infections

Identifier Type: -

Identifier Source: org_study_id

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