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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000756-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Research Foundation Flanders | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tight glucose control | Experimental | Target normal fasting blood glucose concentrations (80-110 mg/dl) with insulin therapy, administered through continuous intravenous infusion. |
|
| Liberal glucose control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ICU dependency | crude number of days with need for vital organ support and time to live discharge from ICU | up to 1 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Mortality | up to 1 year after randomization (with and without censoring at 90 days post randomization) | |
| Hospital Mortality | up to 1 year after randomization (with and without censoring at 90 days post randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical markers on blood samples | 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 |
Inclusion Criteria:
- Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greet Van den Berghe, MD, PhD | KU Leuven | Study Director |
| Jan Gunst, MD, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Medicine, University Hospital Ghent | Ghent | 9000 | Belgium | |||
| Department of Intensive Care Medicine, Jessa Hospital Hasselt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794168 | Background | van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300. | |
| 16452557 | Background | Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61. doi: 10.1056/NEJMoa052521. |
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Data sharing will be considered only on a collaborative basis with PIs, after evaluation of the proposed study protocol and statistical analysis plan.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 2, 2024 | |
| Reset | Aug 23, 2024 | |
| Release | Nov 17, 2025 | |
| Reset | Dec 4, 2025 | |
| Release | Dec 8, 2025 | |
| Reset | Dec 8, 2025 | |
| Release | Apr 8, 2026 | |
| Reset | Apr 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 2, 2024 | Aug 23, 2024 | |||
| Nov 17, 2025 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| 90-day mortality | up to 90 days post randomization |
| Blood glucose concentrations in ICU | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Duration of ICU dependency | 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 | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Time to (live) discharge from hospital | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Incidence of new infections in ICU | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Type of new infections in ICU | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Duration of antibiotic treatment in ICU | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Time course of daily C-reactive protein in ICU | 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 | 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 | 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 | 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 | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Duration of acute kidney injury | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Rate of recovery from acute kidney injury | 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 | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Rate of recovery from new renal replacement therapy | 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 | 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 | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Time to (live) weaning from hemodynamic support | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Time course of markers of liver dysfunction in ICU | 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 | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Incidence of delirium in ICU (in selected centers) | up to 1 year post randomization, with and without censoring at 90 days post randomization |
| Rehabilitation/functional outcome | 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 | 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 | 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 | up to 4 years post randomization (in selected centers) |
| Muscle strength | including handgrip strength as % of the predicted value | up to 4 years post randomization (in selected centers) |
| Rehabilitation/Functional outcome | including the 6-minutes walking distance in meter | up to 4 years post randomization (in selected centers) |
| Rehabilitation/Functional outcome | 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 | up to 4 years post randomization (in selected centers) |
| Survival | up to 4 years post randomization (in selected centers) |
| Use of intensive care resources during index hospitalization | up to 1 year post randomization |
assessed by microscopy |
| up to 30 days post randomization (in selected centers) |
| Biochemical markers in muscle tissue during ICU stay | 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 | assessed by microscopy | up to 30 days post randomization (in selected centers) |
| Biochemical markers in fat tissue during ICU stay | 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 | assessed by microscopy | up to 4 years post randomization (in selected centers) |
| Biochemical markers in muscle tissue | 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 | assessed by microscopy | up to 4 years post randomization (in selected centers) |
| Biochemical markers in fat tissue | including tissular glucose and metabolites, lipid metabolites, mitochondrial complex activity, autophagy markers, (epi)genetic markers | up to 4 years post randomization (in selected centers) |
| Hasselt |
| 3500 |
| Belgium |
| Department of Intensive Care Medicine, University Hospitals Leuven | Leuven | 3000 | Belgium |
| Medical Intensive Care Unit, University Hospitals Leuven | Leuven | 3000 | Belgium |
| 19176240 | Background | Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26. |
| 19318384 | Background | NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24. |
| 21714640 | Background | Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29. |
| 26975590 | Background | Fivez T, Kerklaan D, Mesotten D, Verbruggen S, Wouters PJ, Vanhorebeek I, Debaveye Y, Vlasselaers D, Desmet L, Casaer MP, Garcia Guerra G, Hanot J, Joffe A, Tibboel D, Joosten K, Van den Berghe G. Early versus Late Parenteral Nutrition in Critically Ill Children. N Engl J Med. 2016 Mar 24;374(12):1111-22. doi: 10.1056/NEJMoa1514762. Epub 2016 Mar 15. |
| 37754283 | Derived | Gunst J, Debaveye Y, Guiza F, Dubois J, De Bruyn A, Dauwe D, De Troy E, Casaer MP, De Vlieger G, Haghedooren R, Jacobs B, Meyfroidt G, Ingels C, Muller J, Vlasselaers D, Desmet L, Mebis L, Wouters PJ, Stessel B, Geebelen L, Vandenbrande J, Brands M, Gruyters I, Geerts E, De Pauw I, Vermassen J, Peperstraete H, Hoste E, De Waele JJ, Herck I, Depuydt P, Wilmer A, Hermans G, Benoit DD, Van den Berghe G; TGC-Fast Collaborators. Tight Blood-Glucose Control without Early Parenteral Nutrition in the ICU. N Engl J Med. 2023 Sep 28;389(13):1180-1190. doi: 10.1056/NEJMoa2304855. |
| 36123593 | Derived | Gunst J, Mebis L, Wouters PJ, Hermans G, Dubois J, Wilmer A, Hoste E, Benoit D, Van den Berghe G. Impact of tight blood glucose control within normal fasting ranges with insulin titration prescribed by the Leuven algorithm in adult critically ill patients: the TGC-fast randomized controlled trial. Trials. 2022 Sep 19;23(1):788. doi: 10.1186/s13063-022-06709-8. |
| Dec 4, 2025 |
| Dec 8, 2025 | Dec 8, 2025 |
| Apr 8, 2026 | Apr 28, 2026 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |