Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02165748
Other study ID # IntraopHypegl&Infections
Secondary ID
Status Recruiting
Phase N/A
First received June 13, 2014
Last updated June 16, 2014
Start date November 2013

Study information

Verified date June 2014
Source University of Roma La Sapienza
Contact Federico Bilotta, Md, PhD
Phone 0039 339 33 708 22
Email bilotta@tiscali.it
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

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


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Age >18

- Undergoing elective or emergency craniototmy

Exclusion Criteria:

- Age <18

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Patients Undergoing Craniotomy for Brain Surgery

Locations

Country Name City State
Italy University of ROme "La Sapienza" Rome

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy 7 days Yes
Secondary survival during the study period 7 days Yes