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Glycemic Instability After Spine Surgery

NCT ID: NCT01975883

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperglycemia

Keywords

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Blood Glucose Postoperative Complications Spine Orthopedic surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beaujon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cyril Dauzac

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cyril Dauzac, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Beaujon

Locations

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Hopital Beaujon

Clichy, Hauts-de-Seine, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 19038564 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19194167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19478664 (View on PubMed)

Other Identifiers

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GLYRACH001

Identifier Type: -

Identifier Source: org_study_id