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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Other: enhanced model predictive control algorithm (eMPC)

• Registration Number: NCT00882427
• Lead Sponsor: B. Braun Melsungen AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eMPC	enhanced model predictive control algorithm (eMPC)	improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Brompton Hospital and Harefield NHS Trust; 🇬🇧 London, United Kingdom