NCT01002482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,684

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 3, 2013

Completed
Last Updated

December 3, 2013

Status Verified

November 1, 2013

Enrollment Period

3.2 years

First QC Date

October 26, 2009

Results QC Date

April 24, 2013

Last Update Submit

November 8, 2013

Conditions

HyperglycemiaCritical Illness

Keywords

HyperglycemiaHypoglycemiaIntensive Care UnitGlucose ControlInsulinComputer ProtocolMetabolic Disorders

Outcome Measures

Primary Outcomes (1)

  • All-cause 90-day Mortality

    Day 90

Secondary Outcomes (9)

  • All-cause 28-day Mortality

    Day 28

  • All-cause Intensive Care Unit Mortality

    Date of discharge from the ICU

  • All-cause In-hospital Mortality

    Day of discharge from the hospital

  • Intensive Care Unit Free Days

    28 days

  • Time Spent in Blood Glucose Target

    Day of discharge from the ICU

  • +4 more secondary outcomes

Study Arms (2)

CGAO-based Glucose Control

EXPERIMENTAL

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

Standard-Care Glucose Gontrol

ACTIVE COMPARATOR

Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.

Device: Standard-Care Glucose Control

Interventions

CGAO-based Glucose ControlDEVICE

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.

Also known as: CGAO, LC_CGAO version1
CGAO-based Glucose Control
Standard-Care Glucose ControlDEVICE

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).

Also known as: Usual care
Standard-Care Glucose Gontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

C.H.U. Hôpital Nord

Amiens, 80054, France

Location

C.H. d'Avignon

Avignon, 84902, France

Location

G.H.U. Nord Hôpital Jean Verdier

Bondy, 93143, France

Location

Polyclinique Jean Vilar

Bruges, 33520, France

Location

Hôpital Sainte-Camille

Bry-sur-Marne, 94366, France

Location

C.H. de Chartres

Chartres, 28018, France

Location

C.H. Châteauroux

Châteauroux, 36019, France

Location

Hôpital Sud-Francilien - Site Corbeil

Corbeil-Essonnes, 91006, France

Location

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

C.H. Victor Jousselin

Dreux, 28012, France

Location

Raymond Poincaré

Garches, 92380, France

Location

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, 85925, France

Location

G.H.U. Sud Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital de Mantes-La-Jolie

Mantes-la-Jolie, 78200, France

Location

Hôpital Paul Desbief

Marseille, 13002, France

Location

C.H.U. La Timone

Marseille, 13005, France

Location

Hôpital Ambroise Paré

Marseille, 13291, France

Location

C.H.U. de -Hôpital Saint-Eloi

Montpellier, 34295, France

Location

C.H.U. Lapeyronie

Montpellier, 34925, France

Location

C.H.U. Nantes - Hôpital Laennec

Nantes, 44093, France

Location

C.H.U. de Nice - Hôpital Saint-Roch

Nice, 06006, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

G.H.U. Pitié-Salpétriêre

Paris, 75651, France

Location

Institut Mutualiste Montsouris

Paris, 75674, France

Location

G.H.U. Nord Claude Bernard

Paris, 75877, France

Location

C.H. de Pau

Pau, 64046, France

Location

CHU de Bordeaux - Groupe Hospitalier Sud, Hôpital Haut Lévêque

Pessac, 33604, France

Location

C.H. René Dubos

Pontoise, 95301, France

Location

C.H. Bourran

Rodez, 12000, France

Location

C.H.U. Hôpitaux de Rouen

Rouen, 76031, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

C.H. Intercommunal - Hôpital Font-Pré

Toulon, 83100, France

Location

C.H.U. Purpan

Toulouse, 31059, France

Location

C.H.U. Rangueil

Toulouse, 31059, France

Location

C.H.R.U. de Tours

Tours, 37044, France

Location

Related Publications (6)

  • 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. doi: 10.1016/j.annfar.2009.05.002. Epub 2009 Jun 4. No abstract available. French.

    PMID: 19500942BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Abstracts 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:S5-271. No abstract available.

    PMID: 18183643BACKGROUND

  • Kalfon P, Le Manach Y, Ichai C, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients. Crit Care. 2015 Apr 8;19(1):153. doi: 10.1186/s13054-015-0851-7.

    PMID: 25888011DERIVED

  • Kalfon P, Giraudeau B, Ichai C, Guerrini A, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):171-181. doi: 10.1007/s00134-013-3189-0. Epub 2014 Jan 14.

    PMID: 24420499DERIVED

MeSH Terms

Conditions

HyperglycemiaCritical IllnessHypoglycemiaInsulin ResistanceMetabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Results Point of Contact

Title
Dr. Pierre Kalfon
Organization
CH Chartres
pkalfon@ch-chartres.fr
003323730303073

Study Officials

  • Pierre Kalfon, MD

    Centre Hospitalier de Chartres

    PRINCIPAL INVESTIGATOR

  • Bruno Riou, MD PhD

    G.H.U. Est, C.H.U. Pitié-Salpétriêre

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

December 3, 2013

Results First Posted

December 3, 2013

Record last verified: 2013-11

Locations

FR(35)