Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients (TGC-fast)

June 2, 2023 updated by: Greet Van den Berghe, KU Leuven

Impact of Tight Blood Glucose Control Within Normal Fasting Ranges With Insulin Titration Prescribed by the Leuven Algorithm in Adult Critically Ill Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Department of Intensive Care Medicine, University Hospital Ghent
      • Hasselt, Belgium, 3500
        • Department of Intensive Care Medicine, Jessa Hospital Hasselt
      • Leuven, Belgium, 3000
        • Department of Intensive Care Medicine, University Hospitals Leuven
      • Leuven, Belgium, 3000
        • Medical Intensive Care Unit, University Hospitals Leuven

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)

Exclusion Criteria:

  • Patients with a do not resuscitate (DNR) order at the time of ICU admission
  • Patients expected to die within 12 hours after ICU admission (= moribund patients)
  • Patients able to receive oral feeding (not critically ill)
  • Patients without arterial and without central venous line and without imminent need to place it as part of ICU management (not critically ill)
  • Patients previously included in the trial (when readmission is within 48 hours post ICU discharge, the trial intervention will be resumed)
  • Patients included in an IMP-RCT of which the PI indicates that co-inclusion is prohibited
  • Patients transferred from a non-participating ICU with a pre-admission ICU stay >7 days
  • Patients planned to receive parenteral nutrition during the first week in ICU
  • Patients suffering from diabetic ketoacidotic or hyperosmolar coma on ICU admission
  • Patients with inborn metabolic diseases
  • Patients with insulinoma
  • Patients known to be pregnant or lactating
  • Informed consent refusal

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tight glucose control
Target normal fasting blood glucose concentrations (80-110 mg/dl) with insulin therapy, administered through continuous intravenous infusion.
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.
Active Comparator: Liberal glucose control
Tolerate hyperglycemia up to 215 mg/dl. In patients requiring insulin therapy, insulin will be titrated to target blood glucose concentrations between 180 and 215 mg/dl.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of ICU dependency
Time Frame: up to 1 year after randomization
crude number of days with need for vital organ support and time to live discharge from ICU
up to 1 year after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ICU Mortality
Time Frame: up to 1 year after randomization (with and without censoring at 90 days post randomization)
up to 1 year after randomization (with and without censoring at 90 days post randomization)
Hospital Mortality
Time Frame: up to 1 year after randomization (with and without censoring at 90 days post randomization)
up to 1 year after randomization (with and without censoring at 90 days post randomization)
90-day mortality
Time Frame: up to 90 days post randomization
up to 90 days post randomization
Blood glucose concentrations in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of ICU dependency
Time Frame: up to 90 days post randomization
crude number of days with need for vital organ support and time to live discharge from ICU
up to 90 days post randomization
Length of stay in hospital
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Time to (live) discharge from hospital
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Incidence of new infections in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Type of new infections in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of antibiotic treatment in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Time course of daily C-reactive protein in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Time to final (live) weaning from mechanical respiratory support in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Number of participants with need for a tracheostomy during ICU stay
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Presence of clinical, electrophysiological and morphological signs of respiratory and peripheral muscle weakness in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization (in selected centers)
up to 1 year post randomization, with and without censoring at 90 days post randomization (in selected centers)
Incidence of acute kidney injury in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of acute kidney injury
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Rate of recovery from acute kidney injury
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Number of participants with need for new renal replacement therapy in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Rate of recovery from new renal replacement therapy
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Number of participants with need for hemodynamic support in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
Hemodynamic support is defined as the need for either pharmacological (inotropes/vasopressors) and/or mechanical hemodynamic support.
up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of hemodynamic support in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Time to (live) weaning from hemodynamic support
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Time course of markers of liver dysfunction in ICU
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
including transaminases, gamma-glutamyltransferase, alkaline phosphatase and bilirubin
up to 1 year post randomization, with and without censoring at 90 days post randomization
Number of readmissions to the ICU within 48 hours after discharge
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Incidence of delirium in ICU (in selected centers)
Time Frame: up to 1 year post randomization, with and without censoring at 90 days post randomization
up to 1 year post randomization, with and without censoring at 90 days post randomization
Rehabilitation/functional outcome
Time Frame: up to 2 years post randomization
including the score obtained from the 36-item short form health survey (SF-36). The score ranges from 0 to 100, with 100 being the best possible outcome.
up to 2 years post randomization
Rehabilitation/functional outcome in patients with brain injury
Time Frame: up to 1 year post randomization
including the score obtained on the modified Rankin scale. The score ranges from 0 to 6, with 0 being the best possible outcome.
up to 1 year post randomization
Rehabilitation/functional outcome in patients with brain injury
Time Frame: up to 1 year post randomization
including the score obtained on the extended Glasgow outcome scale. The score ranges from 1 to 8, with 8 being the best possible outcome.
up to 1 year post randomization
Blood lipid concentrations in ICU
Time Frame: up to 4 years post randomization (in selected centers)
up to 4 years post randomization (in selected centers)
Muscle strength
Time Frame: up to 4 years post randomization (in selected centers)
including handgrip strength as % of the predicted value
up to 4 years post randomization (in selected centers)
Rehabilitation/Functional outcome
Time Frame: up to 4 years post randomization (in selected centers)
including the 6-minutes walking distance in meter
up to 4 years post randomization (in selected centers)
Rehabilitation/Functional outcome
Time Frame: up to 4 years post randomization (in selected centers)
including the score obtained from the SF-36 health survey. The score ranges from 0 to 100, with 100 being the best possible outcome.
up to 4 years post randomization (in selected centers)
Rate of recovery of organ function
Time Frame: up to 4 years post randomization (in selected centers)
up to 4 years post randomization (in selected centers)
Survival
Time Frame: up to 4 years post randomization (in selected centers)
up to 4 years post randomization (in selected centers)
Use of intensive care resources during index hospitalization
Time Frame: up to 1 year post randomization
up to 1 year post randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemical markers on blood samples
Time Frame: up to 4 years post randomization
including amino acid levels, blood lipid levels, cytokines, hypothalamic-pituitary hormones, glucagon, C-peptide, (epi)genetic markers
up to 4 years post randomization
Rate of patients with muscle degeneration during ICU stay
Time Frame: up to 30 days post randomization (in selected centers)
assessed by microscopy
up to 30 days post randomization (in selected centers)
Biochemical markers in muscle tissue during ICU stay
Time Frame: up to 30 days post randomization (in selected centers)
including tissular glucose and metabolites, lipid metabolites, myofibrillary proteins, mitochondrial complex activity, autophagy markers, proteasome activity, (epi)genetic markers
up to 30 days post randomization (in selected centers)
Rate of patients with pathological cellular alterations in fat tissue during ICU stay
Time Frame: up to 30 days post randomization (in selected centers)
assessed by microscopy
up to 30 days post randomization (in selected centers)
Biochemical markers in fat tissue during ICU stay
Time Frame: up to 30 days post randomization (in selected centers)
including tissular glucose and metabolites, lipid metabolites, mitochondrial complex activity, autophagy markers, (epi)genetic markers
up to 30 days post randomization (in selected centers)
Rate of patients with muscle degeneration
Time Frame: up to 4 years post randomization (in selected centers)
assessed by microscopy
up to 4 years post randomization (in selected centers)
Biochemical markers in muscle tissue
Time Frame: up to 4 years post randomization (in selected centers)
including tissular glucose and metabolites, lipid metabolites, myofibrillary proteins, mitochondrial complex activity, autophagy markers, proteasome activity, (epi)genetic markers
up to 4 years post randomization (in selected centers)
Rate of patients with pathological cellular alterations in fat tissue
Time Frame: up to 4 years post randomization (in selected centers)
assessed by microscopy
up to 4 years post randomization (in selected centers)
Biochemical markers in fat tissue
Time Frame: up to 4 years post randomization (in selected centers)
including tissular glucose and metabolites, lipid metabolites, mitochondrial complex activity, autophagy markers, (epi)genetic markers
up to 4 years post randomization (in selected centers)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitaire Ziekenhuizen KU Leuven
Research Foundation Flanders

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Greet Van den Berghe, MD, PhD, KU Leuven
  • Principal Investigator: Jan Gunst, MD, PhD, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S61145
  • 2018-000756-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing will be considered only on a collaborative basis with PIs, after evaluation of the proposed study protocol and statistical analysis plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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