Critical IllnessPhase 3TGC-fastNCT03665207
Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients
A Phase 3 study testing Insulin in people with Critical Illness and Hyperglycemia, run by KU Leuven at 4 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Hyperglycemia
- What is being tested?
- Insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,230 participants
- Where
- 4 sitesBelgium
- Study dates
- 18 Sep 2018to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Department of Intensive Care Medicine, University Hospital Ghent
Ghent, 9000
Department of Intensive Care Medicine, Jessa Hospital Hasselt
Hasselt, 3500
Department of Intensive Care Medicine, University Hospitals Leuven
Leuven, 3000
Medical Intensive Care Unit, University Hospitals Leuven
Leuven, 3000
About this study
Official title: 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.
- Conditions
- Critical Illness, Hyperglycemia
- Being tested
- Insulin
- Medical subject headings
- Critical Illness, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tight glucose control | Experimental | Target normal fasting blood glucose concentrations (80-110 mg/dl) with insulin therapy, administered through continuous intravenous infusion. Receives: Drug: Insulin |
| 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. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of ICU dependency
crude number of days with need for vital organ support and time to live discharge from ICU
Measured: up to 1 year after randomization
Secondary outcomes (35)
ICU Mortality
Measured: up to 1 year after randomization (with and without censoring at 90 days post randomization)
Hospital Mortality
Measured: up to 1 year after randomization (with and without censoring at 90 days post randomization)
90-day mortality
Measured: up to 90 days post randomization
Blood glucose concentrations in ICU
Measured: 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
Measured: up to 90 days post randomization
Length of stay in hospital
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Time to (live) discharge from hospital
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Incidence of new infections in ICU
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Type of new infections in ICU
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of antibiotic treatment in ICU
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Time course of daily C-reactive protein in ICU
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of acute kidney injury
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Rate of recovery from acute kidney injury
Measured: 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
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Rate of recovery from new renal replacement therapy
Measured: 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.
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Duration of hemodynamic support in ICU
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Time to (live) weaning from hemodynamic support
Measured: 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
Measured: 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
Measured: up to 1 year post randomization, with and without censoring at 90 days post randomization
Incidence of delirium in ICU (in selected centers)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1 year post randomization
Blood lipid concentrations in ICU
Measured: up to 4 years post randomization (in selected centers)
Muscle strength
including handgrip strength as % of the predicted value
Measured: up to 4 years post randomization (in selected centers)
Rehabilitation/Functional outcome
including the 6-minutes walking distance in meter
Measured: 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.
Measured: up to 4 years post randomization (in selected centers)
Rate of recovery of organ function
Measured: up to 4 years post randomization (in selected centers)
Survival
Measured: up to 4 years post randomization (in selected centers)
Use of intensive care resources during index hospitalization
Measured: up to 1 year post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start18 Sep 2018
- Primary completion30 Nov 2022
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Research Foundation Flanders
- Responsible party
- Principal investigator, Greet Van den Berghe, KU Leuven
- Investigators
- Greet Van den Berghe, MD, PhD, Study director, KU LeuvenJan Gunst, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665207
- Sponsor's protocol ID
- S61145
- Other IDs
- 2018-000756-17, 2018
- Acronym
- TGC-fast
- Status last verified
- Jun 2023
- First submitted
- 29 Aug 2018
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be considered only on a collaborative basis with PIs, after evaluation of the proposed study protocol and statistical analysis plan.
Publications
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.
PubMed 11794168Van 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.
PubMed 16452557Vlasselaers 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.
PubMed 19176240NICE-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.
PubMed 19318384Casaer 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.
PubMed 21714640Fivez 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.
PubMed 26975590Gunst 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.
PubMed 37754283Gunst 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.
PubMed 36123593
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tight Blood Glucose Control Within Normal Fasting Ranges With Insulin Titration Prescribed by the Leuven Algorithm in Adult Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03665207
- Acronym / sponsor ID
- TGC-fast / S61145
- Conditions
- Critical Illness, Hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,230 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Research Foundation Flanders
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight glucose control | Experimental | Drug: InsulinTarget normal fasting blood glucose concentrations (80-110 mg/dl) with insulin therapy, administered through continuous intravenous infusion. |
| Liberal glucose control | Active comparator | Drug: InsulinTolerate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinWhen 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. | Drug | Liberal glucose control, Tight glucose control |
Primary outcome
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
35 secondary outcomes
ICU Mortality
Time frame: 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)
90-day mortality
Time frame: 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
Duration of ICU dependency
Time frame: 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
Time to (live) discharge from hospital
Time frame: 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
Type of new infections in ICU
Time frame: 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
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
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
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
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)
Incidence of acute kidney injury in ICU
Time frame: 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
Rate of recovery from acute kidney injury
Time frame: 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
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
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
Duration of hemodynamic support in ICU
Time frame: 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
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
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
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
Rehabilitation/functional outcome
Time frame: up to 2 years post randomization
Rehabilitation/functional outcome in patients with brain injury
Time frame: up to 1 year post randomization
Rehabilitation/functional outcome in patients with brain injury
Time frame: up to 1 year post randomization
Blood lipid concentrations in ICU
Time frame: up to 4 years post randomization (in selected centers)
Muscle strength
Time frame: up to 4 years post randomization (in selected centers)
Rehabilitation/Functional outcome
Time frame: up to 4 years post randomization (in selected centers)
Rehabilitation/Functional outcome
Time frame: 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)
Survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 11794168van 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.
- Background: PubMed 16452557Van 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.
- Background: PubMed 19176240Vlasselaers 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.
- Background: PubMed 19318384NICE-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.
- Background: PubMed 21714640Casaer 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.
- Background: PubMed 26975590Fivez 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.
- Derived from this study: PubMed 37754283Gunst 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.
- Derived from this study: PubMed 36123593Gunst 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greet Van den Berghe, MD, PhD study director
KU Leuven
Jan Gunst, MD, PhD principal investigator
KU Leuven
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin in people with Critical Illness and Hyperglycemia, run by KU Leuven at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of ICU dependency (time frame: up to 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665207, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.