Glycemic Instability After Spine Surgery

N/ACompletedNCT01975883

Beaujon Hospital91 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hyperglycemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Beaujon

Clichy, Hauts-de-Seine, France

Outcomes

Primary Outcomes

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

Time frame: 6 times a day, for 3 days after surgery

Secondary Outcomes

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.

Time frame: 6 weeks after surgery for each patient

Data from ClinicalTrials.gov

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