Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery) (DexGlySurg)

July 4, 2019 updated by: Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes

Hyperglycemic Response to Steroid Administration After Noncardiac Surgery in Patients With and Without Diabetes

The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include > 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

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
    • Gard
      • Nîmes, Gard, France, 30000
        • Cuvillon

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

Non-Probability Sample

Study Population

Diabetes (non insulin) or healthy patient scheduled for surgery under anesthesia

Description

Inclusion Criteria:

  • elective surgery under anesthesia

Exclusion Criteria:

  • < 50 kg
  • emergency
  • insulin therapy
  • cardiac surgery
  • refusal
  • hyperglycemia> 2g/L

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetes
Patient with non insulin diabetes
Drug: Steroid Drug
mesure of the glucose concentration
control
Patient without diabete
Drug: Steroid Drug
mesure of the glucose concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucose concentration
Time Frame: 6-8 hour
6-8 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
glucose concentration
Time Frame: 12 hour
12 hour
glucose concentraion
Time Frame: 24 hour
24 hour

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

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 (Actual)

September 4, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUNimes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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