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NCT03390179 Clinical Trial

Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)

Healthy Clinical Trial

— DexGlySurg  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03390179
Other study ID # CHUNimes
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2017
Est. completion date February 28, 2018

Study information
Verified date July 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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)

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective surgery under anesthesia

Exclusion Criteria:

- < 50 kg

- emergency

- insulin therapy

- cardiac surgery

- refusal

- hyperglycemia> 2g/L

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Steroid Drug
mesure of the glucose concentration

Locations
Country Name City State
France Cuvillon Nîmes Gard

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary glucose concentration 6-8 hour
Secondary glucose concentration 12 hour
Secondary glucose concentraion 24 hour
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