Computerized Glucose Control in Critically Ill Patients (CGAO-REA)

This study has been completed.
Sponsor:
Collaborators:
Société Française d'Anesthésie et de Réanimation
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Pierre KALFON, Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier:
NCT01002482
First received: October 26, 2009
Last updated: November 8, 2013
Last verified: November 2013
Results First Received: April 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hyperglycemia
Critical Illness
Interventions: Device: CGAO-based Glucose Control
Device: Standard-Care Glucose Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients who were assumed to require at least 3 days in the ICU were eligible for inclusion. The study, carried out between October 2009 and June 2011, involved 34 ICUs (19 in academic tertiary care hospitals and 15 in community hospitals)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
876 participants were eligible but were excluded: 844 Had objection of the treating physician, 32 declined to participate

Reporting Groups
  Description
CGAO-based Glucose Control Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
Standard-Care Glucose Gontrol Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.

Participant Flow:   Overall Study
    CGAO-based Glucose Control     Standard-Care Glucose Gontrol  
STARTED     1351     1333  
COMPLETED     1336     1312  
NOT COMPLETED     15     21  
Withdrawal by Subject                 14                 21  
Included twice                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Among the 2684 randomized patients, 1351 were assigned to tight computerized glucose control and 1333 to conventional glucose control. Thirty six patients were discarded from any analysis, 35 because they withdrew consent and 1 because he/she was included twice. Baseline analysis was performed only for the 2648 included and not discarded patients.

Reporting Groups
  Description
CGAO-based Glucose Control Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
Standard-Care Glucose Gontrol Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Total Total of all reporting groups

Baseline Measures
    CGAO-based Glucose Control     Standard-Care Glucose Gontrol     Total  
Number of Participants  
[units: participants]
  1336     1312     2648  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     720     722     1442  
>=65 years     616     590     1206  
Age  
[units: years]
Mean ± Standard Deviation
  61.5  ± 16.2     61.6  ± 16.2     61.5  ± 16.2  
Gender  
[units: participants]
     
Female     474     468     942  
Male     862     844     1706  
Region of Enrollment  
[units: participants]
     
France     1336     1312     2648  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   All-cause 90-day Mortality   [ Time Frame: Day 90 ]

2.  Secondary:   All-cause 28-day Mortality   [ Time Frame: Day 28 ]

3.  Secondary:   All-cause Intensive Care Unit Mortality   [ Time Frame: Date of discharge from the ICU ]

4.  Secondary:   All-cause In-hospital Mortality   [ Time Frame: Day of discharge from the hospital ]

5.  Secondary:   Intensive Care Unit Free Days   [ Time Frame: 28 days ]

6.  Secondary:   Severe Hypoglycemia   [ Time Frame: Date of discharge from the ICU ]

7.  Secondary:   Hospital Length of Stay   [ Time Frame: Date of discharge from the hospital ]

8.  Secondary:   Intensive Care Unit Length of Stay   [ Time Frame: Date of discharge from the ICU ]

9.  Secondary:   Time Spent in Blood Glucose Target   [ Time Frame: Day of discharge from the ICU ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Incidence of Nosocomial Bacteriemia   [ Time Frame: Date of discharge from the ICU ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Pierre Kalfon
Organization: CH Chartres
phone: 003323730303073
e-mail: pkalfon@ch-chartres.fr


Publications:
Guerrini A; Roudillon G; Gontier O; Rebaï L; Isorni MA; Mutinelli-Szymanski P; Sorine M; Kalfon P. High glycemic variability induced by inappropriate algorithms for intensive insulinotherapy: the example of the NICE-SUGAR study. Abstract award winners: The best pre-selected abstracts of the 22th Annual Congress of the European Society of Intensive Care Medicine, 11-14 October 2009, Vienna, Austria. Intensive Care Med. 2009 Sep;35 Suppl 1:S111.
Gontier O; Hamrouni M; Lherm T; Monchamps G; Ouchenir A; Kalfon P. The CGAO software improves glycaemic control in intensive care patients without increasing the incidence of severe hypoglycaemia nor the nurse workload. Abstracts of the 21th Annual Congress of the European Society of Intensive Care Medicine, 21-24 September 2007, Lisbon, Portugal. Intensive Care Med. 2008 Sep;34 Suppl 2:S220.
Kalfon P; Marie C; Gontier O; Riou B. Improvement of glycaemic control in critically ill patients with the software CGAO. Abstract of the 20th Annual Congress of the European Society of Intensive Care Medicine, 7-10 October 2007, Berlin, Germany. Intensive Care Med. 2007 Sep;33 Suppl 2:S54.

Publications automatically indexed to this study:

Responsible Party: Dr Pierre KALFON, Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier: NCT01002482     History of Changes
Other Study ID Numbers: CGAO-REA-01
Study First Received: October 26, 2009
Results First Received: April 24, 2013
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)