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

Primary Purpose

Critical Illness

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Human insulin - Insulin administration to control blood glucose level.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring blood glucose target, ICU, insulin, hypoglycemia, hyperglycemia, glycated hemoglobin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hôpital Nord Franche Comte
  • CH de Bourg-en-Bresse
  • Centre Hospitalier de Bourgoin-Jallieu
  • CH Chartres
  • CHU de Clermont Ferrand - Gabriel Montpied
  • CHU de Dijon - Complexe Hospitalier du Bocage
  • CHU de Montpellier - Hôpital Lapeyronie
  • CHU de Nice - Hôpital de l'Archet 1
  • CH de Polynésie Française
  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
  • Centre Hospitalier de Salon de Provence
  • CHU de Saint Etienne - Hôpital Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized blood glucose target

Conventional blood glucose target

Arm Description

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).

Maintain blood glucose bellow 10 mmol/l.

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

All-cause mortality
Length of intensive care unit stay
Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)

Full Information

First Posted
September 11, 2014
Last Updated
January 2, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02244073
Brief Title
Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.
Acronym
CONTROLING
Official Title
Individualized Blood Glucose Control in ICU.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Data safety monitoring board decision
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
blood glucose target, ICU, insulin, hypoglycemia, hyperglycemia, glycated hemoglobin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2069 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized blood glucose target
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional blood glucose target
Arm Type
Active Comparator
Arm Description
Maintain blood glucose bellow 10 mmol/l.
Intervention Type
Drug
Intervention Name(s)
Human insulin - Insulin administration to control blood glucose level.
Intervention Description
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 Measure Information:
Title
All-cause mortality
Time Frame
90 days after randomization
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
28 days after randomization and at ICU discharge
Title
Length of intensive care unit stay
Time Frame
90 days
Title
Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
Time Frame
during ICU stay (on average 10 days)
Title
incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)
Time Frame
during ICU stay (on average 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien BOHE, MD PhD
Organizational Affiliation
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Nord Franche Comte
City
Belfort
Country
France
Facility Name
CH de Bourg-en-Bresse
City
Bourg-en-Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Centre Hospitalier de Bourgoin-Jallieu
City
Bourgoin Jallieu
ZIP/Postal Code
38302
Country
France
Facility Name
CH Chartres
City
Chartres
Country
France
Facility Name
CHU de Clermont Ferrand - Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU de Dijon - Complexe Hospitalier du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice - Hôpital de l'Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CH de Polynésie Française
City
Papeete
Country
France
Facility Name
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Hospitalier de Salon de Provence
City
Salon de Provence
ZIP/Postal Code
13658
Country
France
Facility Name
CHU de Saint Etienne - Hôpital Nord
City
St Priest en Jarez
ZIP/Postal Code
42277
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34590159
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.
Results Reference
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Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.

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