Blood Glucose Concentration & Craniotomy

NCT01923571 | Unknown DMC

• 1 other identifier: 2241985
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (1)

• Blood glucose control during craniotomy: epidemiology and relationship with postoperative infections

  7 postoperative days

Secondary Outcomes (1)

• Incidence of postoperative infections according the CDC criteria up to the 7th postoperative day

  7th postoperative day

Other Outcomes (1)

• Intraoperative hyperglycemia (BGC>180mg/dl) and hypoglycemia (BGC<80 mg/dl)

  8 hours

Study Arms (2)

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

Interventions

intraoperative BGC measure OTHER

Hyperglycemia; Normoglycemia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

at least 28 patients in each group

You may qualify if:

• patients undergoing craniotomy

You may not qualify if:

• age \<18 years

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

Policlinico Umberto I, Rome, Italy

Rome, Italy

RECRUITING

Central Study Contacts

Federico Bilotta, MD

CONTACT

bilotta@tiscali.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

IT (2)