NCT05775770

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2024

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

March 7, 2023

Last Update Submit

April 4, 2023

Conditions

Keywords

glucose controlinsulin

Outcome Measures

Primary Outcomes (1)

  • glycemic variability

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

    48 hours

Secondary Outcomes (2)

  • adverse outcomes

    48 hours

  • Analysis of nursing workload

    48 hours

Interventions

insulin therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients admitted to intensive care or intensive care.

You may qualify if:

  • Patient with hyperglycaemia requiring an insulin prescription within 48 hours of admission
  • Expected duration of hospitalization greater than or equal to 48 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen

Caen, France

RECRUITING

MeSH Terms

Conditions

HyperglycemiaInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Laurent Papazian

    French Society for Intensive Care

    STUDY DIRECTOR

Central Study Contacts

Laurent Poiroux

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 20, 2023

Study Start

March 20, 2023

Primary Completion

March 12, 2024

Study Completion

March 12, 2024

Last Updated

April 6, 2023

Record last verified: 2023-03

Locations