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Glycemic Instability After Spine Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01975883
Acronym
GLYRACH
Enrollment
91
Registered
2013-11-05
Start date
2010-07-31
Completion date
2011-01-31
Last updated
2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Keywords

Blood Glucose, Postoperative Complications, Spine, Orthopedic surgery

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.

Interventions

None listed

Sponsors

Beaujon Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in capillary blood glucose levels6 times a day, for 3 days after surgeryBlood 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

MeasureTime frameDescription
postoperative local or general, surgical or medical, complication6 weeks after surgery for each patientPatients 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026