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

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ClinicalTrials.gov Identifier: NCT02244073
Recruitment Status : Terminated (Data safety monitoring board decision)
First Posted : September 18, 2014
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Critical Illness Drug: Human insulin - Insulin administration to control blood glucose level. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2069 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Individualized Blood Glucose Control in ICU.
Study Start Date : May 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Individualized blood glucose target
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).
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).

Active Comparator: Conventional blood glucose target
Maintain blood glucose bellow 10 mmol/l.
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).




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 90 days after randomization ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days after randomization and at ICU discharge ]
  2. Length of intensive care unit stay [ Time Frame: 90 days ]
  3. Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics [ Time Frame: during ICU stay (on average 10 days) ]
  4. incidence and severity of severe hypoglycemia (less than 2.2 mmol/l) [ Time Frame: during ICU stay (on average 10 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244073


Locations
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France
Hôpital Nord Franche Comte
Belfort, France
CH de Bourg-en-Bresse
Bourg-en-Bresse, France, 01012
Centre Hospitalier de Bourgoin-Jallieu
Bourgoin Jallieu, France, 38302
CH Chartres
Chartres, France
CHU de Clermont Ferrand - Gabriel Montpied
Clermont Ferrand, France, 63003
CHU de Dijon - Complexe Hospitalier du Bocage
Dijon, France, 21079
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHU de Nice - Hôpital de l'Archet 1
Nice, France, 06202
CH de Polynésie Française
Papeete, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Centre Hospitalier de Salon de Provence
Salon de Provence, France, 13658
CHU de Saint Etienne - Hôpital Nord
St Priest en Jarez, France, 42277
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Julien BOHE, MD PhD Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02244073     History of Changes
Other Study ID Numbers: 2013.808
2013-A00806-39 ( Other Identifier: ANSM )
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Hospices Civils de Lyon:
blood glucose target
ICU
insulin
hypoglycemia
hyperglycemia
glycated hemoglobin

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs