NCT00882427

Brief Summary

Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 5, 2010

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

April 15, 2009

Last Update Submit

February 4, 2010

Conditions

Critical Illness

Keywords

algorithmtight glycemic controlglucose controlintensive careinsulinICU

Outcome Measures

Primary Outcomes (1)

  • percentage of time within the predefined glucose target range of 80-150 mg/dL

    from start of treatment to the last glucose measurement under treatment

Secondary Outcomes (3)

  • Hypoglycemias

    from start of treatment to the last glucose measurement under treatment

  • Usability parameters like convenience of alarming function; workload; blood sampling frequency

    from start of treatment to the last glucose measurement under treatment

  • Concomitant medication including insulin infusion rate, parenteral/enteral nutrition

    from start of treatment to the last glucose measurement under treatment

Study Arms (1)

eMPC

EXPERIMENTAL

improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients

Other: enhanced model predictive control algorithm (eMPC)

Interventions

enhanced model predictive control algorithm (eMPC)OTHER

eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control

eMPC

Eligibility Criteria

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

You may qualify if:

  • Age: \> 18 years of age
  • Admitted following cardiac surgery
  • Stay in the ICU expected to be \> 20h
  • Blood glucose \> 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment

You may not qualify if:

  • Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
  • Known or suspected allergy to insulin
  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures)
  • Patients participating in another study
  • Moribund patients likely to die within 24 hours
  • Patients after organ transplantation within the last three months
  • Patients under high dose cortisol treatment (cortisol \> 1000 mg/day or equivalent doses of hydrocortisol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital and Harefield NHS Trust

London, United Kingdom

Location

Related Publications (1)

  • Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.

    PMID: 18661120BACKGROUND

MeSH Terms

Conditions

Critical IllnessInsulin Resistance

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jeremy Cordingley, Dr.

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 5, 2010

Record last verified: 2010-02

Locations

GB(1)