Computerized Glucose Control in Critically Ill Patients - Full Text View

Sponsor:	Centre Hospitalier of Chartres
Collaborators:	Société Française d'Anesthésie et de Réanimation (SFAR) Baxter Healthcare Corporation
Information provided by (Responsible Party):	Dr Pierre KALFON, Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier:	NCT01002482

Purpose

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	Intervention	Phase
Hyperglycemia Critical Illness	Device: CGAO-based Glucose Control Device: Standard-Care Glucose Control	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Centre Hospitalier of Chartres:

Primary Outcome Measures:

All-cause 90-day mortality [ Time Frame: Day 120 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All-cause 28-day mortality [ Time Frame: Day 120 ] [ Designated as safety issue: Yes ]
All-cause Intensive Care Unit mortality [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
All-cause in-hospital mortality [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
Intensive care unit free days [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Time spent in blood glucose target [ Time Frame: Day of discharge from the ICU ] [ Designated as safety issue: No ]
Incidence and severity of hypoglycemia [ Time Frame: Day 120 ] [ Designated as safety issue: Yes ]
Hospital Length of Stay [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
Intensive Care Unit Length of Stay [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
Incidence of Nosocomial Bacteriemia [ Time Frame: Day 120 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	6422
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002482

Locations

France
C.H.U. Hôpital Nord
Amiens, France, 80054
G.H.U. Nord Hôpital Jean Verdier
Bondy, France, 93143
Hôpital Sainte-Camille
Bry sur Marne, France, 94366
C.H. de Chartres
Chartres, France, 28018
C.H. Châteauroux
Chateauroux, France, 36019
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
Hôpital Ambroise Paré
Marseille, France, 13291
C.H.U. La Timone
Marseille, France, 13005
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
G.H.U. Nord Claude Bernard
Paris, France, 75877
G.H.U. Pitié-Salpétriêre
Paris, France, 75651
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.U. Hôpitaux de Rouen
Rouen, France, 76031
Hôpital Foch
Suresnes, France, 92151
C.H. Intercommunal - Hôpital Font-Pré
Toulon, France, 83100
C.H.U. Rangueil
Toulouse, France, 31059
C.H.U. Purpan
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 (SFAR)

Baxter Healthcare Corporation

Investigators

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

More Information

Publications:

Carli P, Martin C. [Impact of Nice-Sugar: is there a need for another study on intensive glucose control in ICU?] Ann Fr Anesth Reanim. 2009 Jun;28(6):519-21. Epub 2009 Jun 4. French. No abstract available.

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, principal investigator, Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier:	NCT01002482 History of Changes
Other Study ID Numbers:	CGAO-REA-01
Study First Received:	October 26, 2009
Last Updated:	January 10, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Hospitalier of Chartres:

Hyperglycemia
Hypoglycemia
Intensive Care Unit
Glucose Control

Insulin
Computer Protocol
Metabolic Disorders

Additional relevant MeSH terms:

Critical Illness
Hyperglycemia
Disease Attributes

Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2012