Blood Glucose Management in Intensive Care Units (GINGER)

April 4, 2023 updated by: French Society for Intensive Care

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Caen, France
        • Recruiting
        • CHU Caen
        • Contact:
          • Suzanne Goursaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients admitted to intensive care or intensive care.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycemic variability
Time Frame: 48 hours
Study the impact of glycemic management protocols on the glycemic variability of patients hospitalized in intensive care
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse outcomes
Time Frame: 48 hours
incidence of hypoglycaemia
48 hours
Analysis of nursing workload
Time Frame: 48 hours
nurse / patient ratio
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Society for Intensive Care

Investigators

  • Study Director: Laurent Papazian, French Society for Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Anticipated)

March 12, 2024

Study Completion (Anticipated)

March 12, 2024

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01304-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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