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

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ClinicalTrials.gov Identifier: NCT01002482
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : December 3, 2013
Last Update Posted : December 3, 2013
Sponsor:
Collaborators:
Société Française d'Anesthésie et de Réanimation
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Pierre KALFON, Centre Hospitalier of Chartres

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hyperglycemia
Critical Illness
Interventions Device: CGAO-based Glucose Control
Device: Standard-Care Glucose Control
Enrollment 2684
Recruitment Details 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 876 participants were eligible but were excluded: 844 Had objection of the treating physician, 32 declined to participate
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description 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. Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Period Title: Overall Study
Started 1351 1333
Completed 1336 1312
Not Completed 15 21
Reason Not Completed
Withdrawal by Subject             14             21
Included twice             1             0
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol Total
Hide Arm/Group Description 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. Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l. Total of all reporting groups
Overall Number of Baseline Participants 1336 1312 2648
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1336 participants 1312 participants 2648 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
720
  53.9%
722
  55.0%
1442
  54.5%
>=65 years
616
  46.1%
590
  45.0%
1206
  45.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1336 participants 1312 participants 2648 participants
61.5  (16.2) 61.6  (16.2) 61.5  (16.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1336 participants 1312 participants 2648 participants
Female
474
  35.5%
468
  35.7%
942
  35.6%
Male
862
  64.5%
844
  64.3%
1706
  64.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 1336 participants 1312 participants 2648 participants
1336 1312 2648
1.Primary Outcome
Title All-cause 90-day Mortality
Hide Description [Not Specified]
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Measure Type: Number
Unit of Measure: participants
431 447
2.Secondary Outcome
Title All-cause 28-day Mortality
Hide Description [Not Specified]
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Measure Type: Number
Unit of Measure: participants
326 328
3.Secondary Outcome
Title All-cause Intensive Care Unit Mortality
Hide Description [Not Specified]
Time Frame Date of discharge from the ICU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Measure Type: Number
Unit of Measure: participants
302 310
4.Secondary Outcome
Title All-cause In-hospital Mortality
Hide Description [Not Specified]
Time Frame Day of discharge from the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Measure Type: Number
Unit of Measure: participants
376 393
5.Secondary Outcome
Title Intensive Care Unit Free Days
Hide Description Intensive care unit free days was 28-day-ICU-free-days i.e. was calculated by subtracting the actual ICU duration in days from 28 with patients who died at day 28 or before being assigned 0 free-days and those who had a stay in ICU of 28 days or more being also assigned 0 free-days
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Median (Inter-Quartile Range)
Unit of Measure: days
14
(0 to 22)
13
(0 to 23)
6.Secondary Outcome
Title Time Spent in Blood Glucose Target
Hide Description [Not Specified]
Time Frame Day of discharge from the ICU
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Severe Hypoglycemia
Hide Description Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs
Time Frame Date of discharge from the ICU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1314 1289
Measure Type: Number
Unit of Measure: participants
174 79
8.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame Date of discharge from the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Median (Inter-Quartile Range)
Unit of Measure: days
20
(10 to 37)
20
(9 to 39)
9.Secondary Outcome
Title Intensive Care Unit Length of Stay
Hide Description [Not Specified]
Time Frame Date of discharge from the ICU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description:
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.
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Overall Number of Participants Analyzed 1336 1312
Median (Inter-Quartile Range)
Unit of Measure: days
9
(5 to 18)
8
(4 to 17)
10.Secondary Outcome
Title Incidence of Nosocomial Bacteriemia
Hide Description [Not Specified]
Time Frame Date of discharge from the ICU
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CGAO-based Glucose Control Standard-Care Glucose Gontrol
Hide Arm/Group Description 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. Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
All-Cause Mortality
CGAO-based Glucose Control Standard-Care Glucose Gontrol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CGAO-based Glucose Control Standard-Care Glucose Gontrol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/1336 (1.50%)      6/1312 (0.46%)    
Metabolism and nutrition disorders     
BG of 40 mg per deciliter or less accompanied with observed or suspected neurological symptoms *  20/1336 (1.50%)  23 6/1312 (0.46%)  9
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CGAO-based Glucose Control Standard-Care Glucose Gontrol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1336 (0.00%)      0/1312 (0.00%)    
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
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.
Responsible Party: Dr Pierre KALFON, Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier: NCT01002482     History of Changes
Other Study ID Numbers: CGAO-REA-01
First Submitted: October 26, 2009
First Posted: October 27, 2009
Results First Submitted: April 24, 2013
Results First Posted: December 3, 2013
Last Update Posted: December 3, 2013