Blood Glucose Concentration & Craniotomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Federico Bilotta, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01923571
First received: August 13, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

Intraoperative blood glucose concentration abnormalities are associated with increased perioperative morbidity and mortality (1-4). Severe intraoperative hyperglycemia (BGC ≥ 200 mg/dl) in patients undergoing craniotomy for urgent/emergent craniotomy after traumatic brain injury complicates 15% of the cases and is associated with higher in-hospital mortality. Intraoperative use of dexamethasone during craniotomy is also known to induce an increase in blood glucose concentration.

The importance of blood glucose concentration in neurosurgical patients is witnessed by the effects of tight blood glucose control on incidence of infections and neurological outcome . Currently available evidence suggest that, in neurosurgical patients, perioperative BGC values should be within the 80-180 mg/dl range .

Data on the prevalence of severe intraoperative hyper (blood glucose concentration >180 mg/dl) and hypoglycemia (blood glucose concentration <80 mg/dl) in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure are lacking as it is not known whether in these patients intraoperative severe hyperglycemia relates to an increased incidence of postoperative infections is unknown.

Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- was to test the hypothesis that severe intraoperative hyperglycemia (blood glucose concentration ≥180mg/dl) is associated with an increased incidence of infections within the first postoperative week (pneumonia, sepsis, urinary and wound and cerebral infections). We also recorded the prevalence of severe intraoperative hyper and hypoglycemia (blood glucose concentration<80 mg/dl) in recruited patients.


Condition Intervention
Craniotomy
Other: intraoperative BGC measure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Glucose Concentration During Craniotomy: Epidemiology and Relationship With Postoperative Infections

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Blood glucose control during craniotomy: epidemiology and relationship with postoperative infections [ Time Frame: 7 postoperative days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of postoperative infections according the CDC criteria up to the 7th postoperative day [ Time Frame: 7th postoperative day ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Intraoperative hyperglycemia (BGC>180mg/dl) and hypoglycemia (BGC<80 mg/dl) [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: April 2013
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normoglycemia
patients with intraoperative BGC in the 80-180 mg/dl range
Other: intraoperative BGC measure
Hyperglycemia
patients with intraoperative BGC exceeding 180 mg/dl
Other: intraoperative BGC measure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

at least 28 patients in each group

Criteria

Inclusion Criteria:

  • patients undergoing craniotomy

Exclusion Criteria:

  • age <18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923571

Contacts
Contact: Federico Bilotta, MD bilotta@tiscali.it

Locations
Italy
Policlinico Umberto I, Rome, Italy Recruiting
Rome, Italy
Contact: Federico Bilotta, MD, PhD    39 3393370822      
Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Federico Bilotta, MD, PhD    39 339 33 708 22      
Principal Investigator: Federico Bilotta, MD, PhD         
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Federico Bilotta, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01923571     History of Changes
Other Study ID Numbers: 2241985
Study First Received: August 13, 2013
Last Updated: June 24, 2014
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

ClinicalTrials.gov processed this record on September 15, 2014