Glycemic Instability After Spine Surgery

Completed

• Conditions: Hyperglycemia

• Registration Number: NCT01975883
• Lead Sponsor: Beaujon Hospital

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-29
• Last Update Submitted: 2013-10-29
• Study First Posted: 2013-11-05
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in capillary blood glucose levels	6 times a day, for 3 days after surgery	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

Secondary Outcome Measures

Name	Time	Method
postoperative local or general, surgical or medical, complication	6 weeks after surgery for each patient	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.

Trial Locations

Locations (1)

Hopital Beaujon; 🇫🇷 Clichy, Hauts-de-Seine, France