Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.

Critical Illness Clinical Trial

— CONTROLING  

Official title:

Individualized Blood Glucose Control in ICU.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02244073
• Other study ID #: 2013.808
• Secondary ID: 2013-A00806-39
• Status: Terminated
• Phase: N/A
• First received: September 11, 2014
• Last updated: January 2, 2018
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2069
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Human insulin - Insulin administration to control blood glucose level.
On ICU admission, the glycated hemoglobin level (A1c) is measured and insulin IV is possibly administered using a web based nurse driven insulin infusion protocol (https://extranet.chu-lyon.fr/cpg) to maintain blood glucose level below 10 mmol/l. Glycated hemoglobin result triggers patient randomization. Thereafter, during ICU stay, blood glucose level is maintained either below 1.59 × A1c - 1.59 (mmol/l) (Individualized blood glucose target group), or bellow 10 mmol/l (Conventional blood glucose target group).

Locations

Country	Name	City	State
France	Hôpital Nord Franche Comte	Belfort
France	CH de Bourg-en-Bresse	Bourg-en-Bresse
France	Centre Hospitalier de Bourgoin-Jallieu	Bourgoin Jallieu
France	CH Chartres	Chartres
France	CHU de Clermont Ferrand - Gabriel Montpied	Clermont Ferrand
France	CHU de Dijon - Complexe Hospitalier du Bocage	Dijon
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Nice - Hôpital de l'Archet 1	Nice
France	CH de Polynésie Française	Papeete
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Hospitalier de Salon de Provence	Salon de Provence
France	CHU de Saint Etienne - Hôpital Nord	St Priest en Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		90 days after randomization
Secondary	All-cause mortality		28 days after randomization and at ICU discharge
Secondary	Length of intensive care unit stay		90 days
Secondary	Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics		during ICU stay (on average 10 days)
Secondary	incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)		during ICU stay (on average 10 days)

External Links

•   Link