Glycemic Instability After Spine Surgery

Hyperglycemia Clinical Trial

— GLYRACH  

Official title:

Glycemic Instability of Non-diabetic Patients After Spine Surgery: a Prospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975883
• Other study ID #: GLYRACH001
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: October 29, 2013
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2013
• Source: Beaujon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperglycemia

Locations

Country	Name	City	State
France	Hopital Beaujon	Clichy	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Beaujon Hospital

Country where clinical trial is conducted

France, 

References & Publications (3)

Lipshutz AK, Gropper MA. Perioperative glycemic control: an evidence-based review. Anesthesiology. 2009 Feb;110(2):408-21. doi: 10.1097/ALN.0b013e3181948a80. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in capillary blood glucose levels	Blood glucose levels are measured at the following times: before being lead to the operating room, fasting ; 2 hours after post anesthesia care unit admission ; 30 min before and 2 hours after breakfast, lunch and dinner on the first postoperative day. The same schedule was repeated on the second and the third day after surgery	6 times a day, for 3 days after surgery	No
Secondary	postoperative local or general, surgical or medical, complication	Patients are followed on consultation by the medical team six weeks after surgery to determine the occurrence of either surgical revision (due to surgical site infection defined by the criteria of the US Centers for Disease Control and Prevention (CDC), mechanical or neurological complication), or any other early local or general complication such as wound healing impairment, deep venous thromboembolic or cardiovascular event.	6 weeks after surgery for each patient	No