Hyperglycemic Response and Steroid Administration After S... | NCT03390179

Studies
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)

NCT03390179

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Diabetes
Healthy

Interventions

Steroid Drug

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Dec 28, 2017

First Submission Date that Met QC Criteria

Dec 28, 2017

First Posted Date

Jan 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2019

Last Update Posted Date

Jul 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Philippe Cuvillon, PhD, Centre Hospitalier Universitaire de NīmesPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diabetes		Patient with non insulin diabetes	Drug: Steroid Drug
control		Patient without diabete	Drug: Steroid Drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Steroid Drug	Drug	mesure of the glucose concentration	control diabetes

Measure	Description	Time Frame
glucose concentration		6-8 hour

Measure	Description	Time Frame
glucose concentration		12 hour
glucose concentraion		24 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery under anesthesia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Cuvillon		Nîmes	Gard	30000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided