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

Not Applicable

Terminated

• Conditions: Critical Illness
• Interventions: Drug: Human insulin - Insulin administration to control blood glucose level.

• Registration Number: NCT02244073
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Study Start: 2015-05
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2069

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized blood glucose target	Human insulin - Insulin administration to control blood glucose level.	Maintain blood glucose in individualized target based on glycated hemoglobin level (A1c); Blood glucose level is maintained bellow 1.59 × A1c - 1.59 (mmol/l).
Conventional blood glucose target	Human insulin - Insulin administration to control blood glucose level.	Maintain blood glucose bellow 10 mmol/l.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	90 days after randomization

Secondary Outcome Measures

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

Trial Locations

Locations (12)

CHU de Saint Etienne - Hôpital Nord; 🇫🇷 St Priest en Jarez, France

Centre Hospitalier de Salon de Provence; 🇫🇷 Salon de Provence, France

CHU de Clermont Ferrand - Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

Hôpital Nord Franche Comte; 🇫🇷 Belfort, France

CH Chartres; 🇫🇷 Chartres, France

CH de Bourg-en-Bresse; 🇫🇷 Bourg-en-Bresse, France

Centre Hospitalier de Bourgoin-Jallieu; 🇫🇷 Bourgoin Jallieu, France

CH de Polynésie Française; 🇫🇷 Papeete, France

CHU de Dijon - Complexe Hospitalier du Bocage; 🇫🇷 Dijon, France

CHU de Nice - Hôpital de l'Archet 1; 🇫🇷 Nice, France

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France