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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia
• Insulin Hypoglycemia

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