Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections

June 16, 2014 updated by: Federico Bilotta, University of Roma La Sapienza
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Recruiting
        • University of ROme "La Sapienza"
        • Principal Investigator:
          • Federico Bilotta, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients undergoing craniotomy for brain surgery

Description

Inclusion Criteria:

  • Age >18
  • Undergoing elective or emergency craniototmy

Exclusion Criteria:

  • Age <18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
survival during the study period
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Federico Bilotta, MD, PhD, Department of Anesthesiology, University of ROme "La Sapienza"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • IntraopHypegl&Infections

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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