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Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients

NCT03665207 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9230

Last updated 2023-06-05

No results posted yet for this study

Summary

Critically ill patients usually develop hyperglycemia, which is associated with an increased risk of morbidity and mortality. Controversy exists on whether targeting normal blood glucose concentrations with insulin therapy, referred to as tight blood glucose control (TGC) improves outcome of these patients, as compared to tolerating hyperglycemia. It remains unknown whether TGC, when applied with optimal tools to avoid hypoglycemia, is beneficial in a context of withholding early parenteral nutrition. The TGC-fast study hypothesizes that TGC is beneficial in adult critically ill patients not receiving early parenteral nutrition, as compared to tolerating hyperglycemia.

Conditions

Interventions

DRUG

Insulin

When blood glucose exceeds the preset target, insulin will be administered through continuous intravenous infusion. Insulin will be titrated according to frequent measurement of blood glucose and with use of the LOGIC-insulin algorithm in the experimental group. The intervention will be stopped upon ICU discharge, or until the patient is able to resume oral feeding, or until the patient no longer has a central venous catheter, whatever comes first.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Research Foundation Flanders

    collaborator OTHER

  • KU Leuven

    lead OTHER

Principal Investigators

  • Greet Van den Berghe, MD, PhD · KU Leuven

  • Jan Gunst, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2022-11-30
Completion
2026-11-30

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03665207 on ClinicalTrials.gov