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NCT Number: NCT00882427

Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit

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.

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Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton Hospital and Harefield NHS Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

enhanced model predictive control algorithm (eMPC)

Other

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

Primary outcomes

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

    Time frame: from start of treatment to the last glucose measurement under treatment

Secondary outcomes

  1. Hypoglycemias

    Time frame: from start of treatment to the last glucose measurement under treatment

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

    Time frame: from start of treatment to the last glucose measurement under treatment

  3. Concomitant medication including insulin infusion rate, parenteral/enteral nutrition

    Time frame: from start of treatment to the last glucose measurement under treatment

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

Single-center, Open Study on the Performance of the Software eMPC Algorithm Used for Blood Glucose Control Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the Intensive Care Unit

Acronym: Aldea_02

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2009
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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