Blood Glucose Concentration & Craniotomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01923571|
Recruitment Status : Unknown
Verified June 2014 by Federico Bilotta, University of Roma La Sapienza.
Recruitment status was: Recruiting
First Posted : August 15, 2013
Last Update Posted : June 25, 2014
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 or disease||Intervention/treatment|
|Craniotomy||Other: intraoperative BGC measure|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||53 participants|
|Official Title:||Blood Glucose Concentration During Craniotomy: Epidemiology and Relationship With Postoperative Infections|
|Study Start Date :||April 2013|
|Primary Completion Date :||June 2014|
patients with intraoperative BGC in the 80-180 mg/dl range
|Other: intraoperative BGC measure|
patients with intraoperative BGC exceeding 180 mg/dl
|Other: intraoperative BGC measure|
- Blood glucose control during craniotomy: epidemiology and relationship with postoperative infections [ Time Frame: 7 postoperative days ]
- Incidence of postoperative infections according the CDC criteria up to the 7th postoperative day [ Time Frame: 7th postoperative day ]
- Intraoperative hyperglycemia (BGC>180mg/dl) and hypoglycemia (BGC<80 mg/dl) [ Time Frame: 8 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923571
|Contact: Federico Bilotta, MDemail@example.com|
|Policlinico Umberto I||Recruiting|
|Rome, Italy, 00161|
|Contact: Federico Bilotta, MD, PhD 39 339 33 708 22|
|Principal Investigator: Federico Bilotta, MD, PhD|
|Policlinico Umberto I, Rome, Italy||Recruiting|
|Contact: Federico Bilotta, MD, PhD 39 3393370822|