Glycemic Instability After Spine Surgery (GLYRACH)

October 29, 2013 updated by: Cyril Dauzac, Beaujon Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92110
        • Hopital Beaujon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Spine surgical patients
Sequential patients scheduled for spine surgery, including degenerative, deformative, tumoral and traumatologic indications are eligible to participate. Exclusion criteria are the following : 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in capillary blood glucose levels
Time Frame: 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
6 times a day, for 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative local or general, surgical or medical, complication
Time Frame: 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.
6 weeks after surgery for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaujon Hospital

Investigators

  • Principal Investigator: Cyril Dauzac, MD, Hopital Beaujon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 29, 2013

First Posted (ESTIMATE)

November 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLYRACH001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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