Clinical trial NCT01975883: Glycemic Instability After Spine Surgery
Official title: Glycemic Instability of Non-diabetic Patients After Spine Surgery: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: Blood Glucose
Postoperative Complications
Spine
Orthopedic surgery
Lead sponsor: Beaujon Hospital
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sequential patients scheduled for spine surgery in our center, including degenerative, deformative, tumoral and traumatologic indications are eligible to participate.

Brief summary: Analyzing peri operative changes in blood glucose levels from non-diabetic patients undergoing spine surgery

Detailed description: Background: Blood glucose (BG) dysregulation is a well-known situation in medical or surgical severe circumstances. However BG levels following spine surgery have never been described before. Our primary purpose is to measure postoperative changes in BG levels of non-diabetic patients undergoing spine surgery.

Methods: Non-diabetic consecutive adult patients undergoing spine surgery are going to be prospectively included during a 6 months period. BG capillary measures are collected from the preoperative fasting period to the end of postoperative day 3, six times a day. Three main glycemic parameters are calculated: Delta Day 0 (DD0), Day 2 mean (D2), and Hyperglycemic Index (HGI). In the peri operative period, no change in oral intake nor in intravenous fluids is prescribed. Patients are followed-up for three months postoperatively for any early adverse event, requiring or not surgical revision.

Eligibility criteria: Inclusion Criteria:

* non diabetic spine surgery candidate

Exclusion Criteria:

* infection or history of infection of surgical site, past medical history of diabetes mellitus, defined as chronic glucose intolerance either insulin-dependent or non insulin-dependent at the time of operation, and patients with preoperative random BG levels greater than 126 mg/dl considering they could also represent undiagnosed diabetes

Primary outcomes:
measure: Changes in capillary blood glucose levels
timeFrame: 6 times a day, for 3 days after surgery
Secondary outcomes:
measure: postoperative local or general, surgical or medical, complication
timeFrame: 6 weeks after surgery for each patient
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital Beaujon
state: Hauts-de-Seine
Study officials:
affiliation: Hopital Beaujon
name: Cyril Dauzac, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pili-Floury S, Mitifiot F, Penfornis A, Boichut N, Tripart MH, Christophe JL, Garbuio P, Samain E. Glycaemic dysregulation in nondiabetic patients after major lower limb prosthetic surgery. Diabetes Metab. 2009 Feb;35(1):43-8. doi: 10.1016/j.diabet.2008.06.007. Epub 2008 Nov 26.
citation: Lipshutz AK, Gropper MA. Perioperative glycemic control: an evidence-based review. Anesthesiology. 2009 Feb;110(2):408-21. doi: 10.1097/ALN.0b013e3181948a80.
citation: Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013.