Severe Intraoperative Hyperglycemia During Craniotomy and... | NCT02165748

Studies
Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections

NCT02165748

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Jun 17, 2014Estimated

Enrollment

28Estimated

Phase

Not provided

Conditions

Patients Undergoing Craniotomy for Brain Surgery

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Sep 2014Estimated

Completion Date

Not provided

First Submitted Date

Jun 13, 2014

First Submission Date that Met QC Criteria

Jun 16, 2014

First Posted Date

Jun 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2014

Last Update Posted Date

Jun 17, 2014Estimated

Description Module

Brief 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 postoperative week (pneumonia, blood stream, urinary, surgical site/wound and cerebral infections)(NCT01923571).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy		7 days

Secondary Outcomes

Measure	Description	Time Frame
survival during the study period		7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18
Undergoing elective or emergency craniototmy

Exclusion Criteria:

Age <18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing craniotomy for brain surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Federico Bilotta, Md, PhD	Contact	0039 339 33 708 22		bilotta@tiscali.it

Overall Officials

Name	Affiliation	Role
Federico Bilotta, MD, PhD	Department of Anesthesiology, University of ROme "La Sapienza"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of ROme "La Sapienza"	Recruiting	Rome		00161	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28181933	Derived	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.