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NCT05775770 Clinical Trial

Blood Glucose Management in Intensive Care Units

Hyperglycemia Clinical Trial

— GINGER  

Official title:
Survey of Practices on the Management of Glycemia in Patients Hospitalized in Intensive Care Units

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05775770
Other study ID # 2022-A01304-39
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2023
Est. completion date March 12, 2024

Study information
Verified date March 2023
Source French Society for Intensive Care
Contact Suzanne Goursaud
Phone 1 45 86 74 00
Email goursaud-s@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. The aim of this study is to carry out an inventory of the current practices of glycemia management as well as their modalities. Being one of the key points of the management, this work will have for main objective to raise the importance of the glycemic variabilities according to the methods of insulin therapies used.

Recruitment information / eligibility
Status Recruiting
Enrollment 525
Est. completion date March 12, 2024
Est. primary completion date March 12, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with hyperglycaemia requiring an insulin prescription within 48 hours of admission - Insulin therapy started less than 12 hours before inclusion of the patient in the study - Expected duration of hospitalization greater than or equal to 48 hours Exclusion Criteria: - Moribund patients - Patients admitted for ketoacidosis or hyperosmolar coma - Patients admitted for symptomatic hypoglycaemia - Patient requiring insulin for serum potassium correction - Severe acute hepatocellular insufficiency - Age < 18 years old - Pregnant or breastfeeding women - Patients under legal protection measures

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin
insulin therapy

Locations
Country Name City State
France CHU Caen Caen

Sponsors (1)
Lead Sponsor Collaborator
French Society for Intensive Care

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycemic variability Study the impact of glycemic management protocols on the glycemic variability of patients hospitalized in intensive care 48 hours
Secondary adverse outcomes incidence of hypoglycaemia 48 hours
Secondary Analysis of nursing workload nurse / patient ratio 48 hours
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