Clinical trial NCT02244073: Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.
Official title: Individualized Blood Glucose Control in ICU.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Critical Illness
Keywords: blood glucose target
ICU
insulin
hypoglycemia
hyperglycemia
glycated hemoglobin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 2069
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the last 2 decades, the management of hyperglycemia in critically ill patients has become one of the most discussed topics in the intensive-care field. The initial data suggesting significant benefit from the normalization of blood glucose levels in critically ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some studies suggested that strict blood glucose control might benefit in non-diabetic patient and worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target based on glycated hemoglobin measured at ICU admission would improve outcome when compared to a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a randomized double blinded study in which Blood glucose control is piloted in both groups by a web-guided protocol that directly gives instruction to nurses (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers. Primary end point is 90 d outcome after randomization.


Eligibility criteria: Inclusion Criteria:

Patients are eligible for INCLUSION in the study if ALL the following criteria are met:

* Patient is 18 year old or older;
* At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission.

Exclusion Criteria:

* Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:

  * Patient or legal surrogate decision maker does not accept the participation to the study;
  * Imminent death (anticipated in less than 48 hours);
  * The treating clinicians are not committed to full supportive care (no resuscitation, no renal replacement therapy limits in dose of vasoactive support);
  * Patient is expected to be eating before the end of the day following admission;
  * Admission in ICU for hypoglycemic encephalopathy or patient at risk for hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure);
  * If a patient has previously been enrolled in the CONTROLING Study (patients cannot be enrolled in the CONTROLING Study more than once).

Primary outcomes:
measure: All-cause mortality
timeFrame: 90 days after randomization
Secondary outcomes:
measure: All-cause mortality
timeFrame: 28 days after randomization and at ICU discharge
measure: Length of intensive care unit stay
timeFrame: 90 days
measure: Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
timeFrame: during ICU stay (on average 10 days)
measure: incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)
timeFrame: during ICU stay (on average 10 days)
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche Comte
city: Bourg-en-Bresse
country: France
facility: CH de Bourg-en-Bresse
city: Bourgoin Jallieu
country: France
facility: Centre Hospitalier de Bourgoin-Jallieu
city: Chartres
country: France
facility: CH Chartres
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Gabriel Montpied
city: Dijon
country: France
facility: CHU de Dijon - Complexe Hospitalier du Bocage
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet 1
city: Papeete
country: France
facility: CH de Polynésie Française
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
city: Salon de Provence
country: France
facility: Centre Hospitalier de Salon de Provence
city: St Priest en Jarez
country: France
facility: CHU de Saint Etienne - Hôpital Nord
Study officials:
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
name: Julien BOHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohe J, Abidi H, Brunot V, Klich A, Klouche K, Sedillot N, Tchenio X, Quenot JP, Roudaut JB, Mottard N, Thiolliere F, Dellamonica J, Wallet F, Souweine B, Lautrette A, Preiser JC, Timsit JF, Vacheron CH, Ait Hssain A, Maucort-Boulch D; CONTROLe INdividualise de la Glycemie (CONTROLING) Study Group. Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial. Intensive Care Med. 2021 Nov;47(11):1271-1283. doi: 10.1007/s00134-021-06526-8. Epub 2021 Sep 29.