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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002482
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : December 3, 2013
Last Update Posted : December 3, 2013
Société Française d'Anesthésie et de Réanimation
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Pierre KALFON, Centre Hospitalier of Chartres

Brief Summary:
The aim of the study is to determine whether the use of the CGAOtm software is associated with a decrease in 90-day mortality when compared with the use of standard care methods for glucose control with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software is designed to assist physicians and nurses in achieving tight glucose control (defined by a target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.

Condition or disease Intervention/treatment Phase
Hyperglycemia Critical Illness Device: CGAO-based Glucose Control Device: Standard-Care Glucose Control Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of the Use of a Computerized Protocol for Glucose Control Named CGAOtm on the Outcome of Critically Ill Patients
Study Start Date : October 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: 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.
Device: CGAO-based Glucose Control

Use of a clinical computerized decision-support system named CGAOtm designed to achieve tight glucose control in various ICU settings, and fine-tuned to reduce glucose variability without increasing the incidence of severe hypoglycemia or nurse workload.

CGAOtm is based on explicit replicable recommendations following each blood glucose measurement for insulin rates and time to next measurement, and reminders, alerts, graphic tools, trends, and individual on-line data aimed at increasing confidence of the nursing staff in the computer protocol and giving care staff a method for controlling the process during the whole ICU stay, according to a "human-in-the-loop" approach.

The algorithm used in the CGAOtm software for the calculation of the recommended insulin rates derived from a PID (Proportional-integral-derivative) controller, a generic control loop feedback mechanism widely used in industrial control.

Other Name: CGAO, LC_CGAO version1

Active Comparator: Standard-Care Glucose Gontrol
Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
Device: Standard-Care Glucose Control
Patients in the control group will receive conventional insulin therapy using the "usual care" protocol of each participating centre (already used in the centre before the beginning of the trial and targeting blood glucose levels inferior to 180 mg/dl).
Other Name: Usual care

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

Secondary Outcome Measures :
  1. All-cause 28-day Mortality [ Time Frame: Day 28 ]
  2. All-cause Intensive Care Unit Mortality [ Time Frame: Date of discharge from the ICU ]
  3. All-cause In-hospital Mortality [ Time Frame: Day of discharge from the hospital ]
  4. Intensive Care Unit Free Days [ Time Frame: 28 days ]
    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

  5. Time Spent in Blood Glucose Target [ Time Frame: Day of discharge from the ICU ]
  6. Severe Hypoglycemia [ Time Frame: Date of discharge from the ICU ]
    Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs

  7. Hospital Length of Stay [ Time Frame: Date of discharge from the hospital ]
  8. Intensive Care Unit Length of Stay [ Time Frame: Date of discharge from the ICU ]
  9. Incidence of Nosocomial Bacteriemia [ Time Frame: Date of discharge from the ICU ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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:

  • Age < 18 years or patient under guardianship.
  • Pregnancy.
  • Moribund patient or imminent death in the ICU (e.g. patient expected to die in the ICU within 24 hours).
  • At time of the patient's admission, the treating physicians are not committed tu full supportive care.
  • Patient admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
  • Patient admitted to the ICU for hypoglycemia.
  • Patient thought to be at abnormally high risk of suffering hypoglycemia (e.g. known insulin secreting tumor or history of unexplained or recurrent hypoglycemia or fulminant hepatic failure).
  • Patient who have suffered hypoglycemia without documented full neurological recovery
  • Patient is expected to be eating before the end of the day following admission.
  • Patient previously enrolled in the CGAO-REA study.

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 identifier (NCT number): NCT01002482

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C.H.U. Hôpital Nord
Amiens, France, 80054
C.H. d'Avignon
Avignon, France, 84902
G.H.U. Nord Hôpital Jean Verdier
Bondy, France, 93143
Polyclinique Jean Vilar
Bruges, France, 33520
Hôpital Sainte-Camille
Bry sur Marne, France, 94366
C.H. de Chartres
Chartres, France, 28018
C.H. Châteauroux
Chateauroux, France, 36019
Hôpital Sud-Francilien - Site Corbeil
Corbeil-Essonnes, France, 91006
Clinique des Cèdres
Cornebarrieu, France, 31700
C.H. Victor Jousselin
Dreux, France, 28012
Raymond Poincaré
Garches, France, 92380
Centre Hospitalier Départemental Les Oudairies
La Roche Sur Yon, France, 85925
G.H.U. Sud Bicêtre
Le Kremlin Bicêtre, France, 94275
Hôpital de Mantes-La-Jolie
Mantes-La-Jolie, France, 78200
Hôpital Paul Desbief
Marseille, France, 13002
C.H.U. La Timone
Marseille, France, 13005
Hôpital Ambroise Paré
Marseille, France, 13291
C.H.U. de -Hôpital Saint-Eloi
Montpellier, France, 34295
C.H.U. Lapeyronie
Montpellier, France, 34925
C.H.U. Nantes - Hôpital Laennec
Nantes, France, 44093
C.H.U. de Nice - Hôpital Saint-Roch
Nice, France, 06006
Hôpital Européen Georges Pompidou
Paris, France, 75015
G.H.U. Pitié-Salpétriêre
Paris, France, 75651
Institut Mutualiste Montsouris
Paris, France, 75674
G.H.U. Nord Claude Bernard
Paris, France, 75877
C.H. de Pau
Pau, France, 64046
CHU de Bordeaux - Groupe Hospitalier Sud, Hôpital Haut Lévêque
Pessac, France, 33604
C.H. René Dubos
Pontoise, France, 95301
C.H. Bourran
Rodez, France, 12000
C.H.U. Hôpitaux de Rouen
Rouen, France, 76031
Hôpital Foch
Suresnes, France, 92151
C.H. Intercommunal - Hôpital Font-Pré
Toulon, France, 83100
C.H.U. Purpan
Toulouse, France, 31059
C.H.U. Rangueil
Toulouse, France, 31059
C.H.R.U. de Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier of Chartres
Société Française d'Anesthésie et de Réanimation
Baxter Healthcare Corporation
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Principal Investigator: Pierre Kalfon, MD Centre Hospitalier de Chartres
Study Director: Bruno Riou, MD PhD G.H.U. Est, C.H.U. Pitié-Salpétriêre
Study Chair: Djillali Annane, MD PhD G.H.U. Ouest, Hôpital Raymond Poincaré
Study Chair: Jean Chastre, MD PhD G.H.U. Est, Pitié-Salpétriêre
Study Chair: Pierre-François Dequin, MD PhD CHRU Tours
Study Chair: Hervé Dupont, MD PhD CHRU Amiens
Study Chair: Carole Ichai, MD PhD CHRU de Nice
Study Chair: Yannick Malledant, MD PhD CHRU Rennes
Study Chair: Philippe Montravers, MD PhD G.H.U. Nord Bichat-Claude Bernard

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 by Identifier (NCT Number):
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Responsible Party: Dr Pierre KALFON, principal investigator, Centre Hospitalier of Chartres Identifier: NCT01002482     History of Changes
Other Study ID Numbers: CGAO-REA-01
First Posted: October 27, 2009    Key Record Dates
Results First Posted: December 3, 2013
Last Update Posted: December 3, 2013
Last Verified: November 2013

Keywords provided by Dr Pierre KALFON, Centre Hospitalier of Chartres:
Intensive Care Unit
Glucose Control
Computer Protocol
Metabolic Disorders

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs