Glycemic Instability After Spine Surgery

NCT01975883 | Completed

• 1 other identifier: GLYRACH001
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperglycemia

Keywords

Blood Glucose; Postoperative Complications; Spine; Orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• postoperative local or general, surgical or medical, complication

  6 weeks after surgery for each patient

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• non diabetic spine surgery candidate

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaujon Hospital: lead

Study Sites (1)

Hopital Beaujon

Clichy, Hauts-de-Seine, 92110, France

Location

Related Publications (3)

• 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.

  PMID: 19038564 BACKGROUND

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

  PMID: 19194167 BACKGROUND

• 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.

  PMID: 19478664 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Postoperative Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cyril Dauzac, MD

  Hopital Beaujon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 5, 2013
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: November 5, 2013

Record last verified: 2013-10

Locations

FR (1)