GINGER: Blood Glucose Management in Intensive Care Units

• Sponsor: French Society for Intensive Care (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05775770
• Collaborator: (none)
• Enrollment: 525
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

We 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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Hypoglycemia; Glucose Test Site Bleeding; Hyperglycemia	Drug: Insulin

Study Design

• Study Type: Observational
• Anticipated Enrollment: 525 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Survey of Practices on the Management of Glycemia in Patients Hospitalized in Intensive Care Units
• Anticipated Study Start Date: Mar 13, 2023
• Anticipated Primary Completion Date: Mar 12, 2024
• Anticipated Study Completion Date: Mar 12, 2024

Outcome Measures

Primary Outcome Measures

1. glycemic variability [48 hours]

   Study the impact of glycemic management protocols on the glycemic variability of patients hospitalized in intensive care

Secondary Outcome Measures

1. adverse outcomes [48 hours]

   incidence of hypoglycaemia

2. Analysis of nursing workload [48 hours]

   nurse / patient ratio

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• French Society for Intensive Care

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: French Society for Intensive Care
• ClinicalTrials.gov Identifier: NCT05775770
• Other Study ID Numbers: 2022-A01304-39
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by French Society for Intensive Care: glucose control; insulin
• Additional relevant MeSH terms: Hypoglycemia; Hyperglycemia; Insulin

Study Results

No Results Posted as of Mar 20, 2023