Glucose Control by eMPC Algorithm in Peri- and Postoperative Period in Cardiac Surgery Patients

NCT ID: NCT00444171

Last Updated: 2007-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-02-28

Brief Summary

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Randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP) in peri- and postoperative period in cardiac surgery patients.

Detailed Description

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Context. Increased blood glucose levels frequently occur in critically ill patients and its normalization by intensive insulin treatment markedly improves clinical outcome.

Objective and Design: Randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP) in peri- and postoperative period in cardiac surgery patients.

Setting: Department of Cardiac Surgery, University Hospital. Patients. 60 cardiac surgery patients. Interventions. Elective cardiac surgery and treatment with continuous insulin infusion to maintain euglycemia (target range 4.4 - 6.1 mmol/l). 30 patients were randomized for eMPC and 30 for RMP treatment. Blood glucose was measured in 1-4 hour intervals depending on request of each algorithm during surgery and post-operation period for 24 hours.

Main Outcome Measures. Mean blood glucose, percentage of time in target range. Results. Mean blood glucose was 6.15 ± 1.11 mmol/l in eMPC vs. 7.21 ± 1.08 mmol/l in RMP group (p\<0.05); percentage of time in target range was 60.4 ± 22.8% for eMPC vs. 27.5 ± 16.2% for RMP group (p\<0.05). No severe hypoglycemia (blood glucose bellow 2.9 mmol/l) was observed during the study. Average insulin infusion rate was 4.67 ± 3.34 in eMPC vs. 2.57 ± 1.66 IU/h in RMP (p\<0.05), average sampling interval was 1.46 ± 0.31 vs. 2.10 ± 0.22 hours (p\<0.05).

Conclusions. eMPC algorithm was more effective and comparably safe as compared to RMP in maintaining euglycemia in cardiac surgery patients.

Conditions

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Cardiac Surgery Patients Blood Glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin infusion rate controled by computer algorithm

Intervention Type PROCEDURE

insulin infusion rate guided by in-house glucose management protocol

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective cardiac surgery

Exclusion Criteria

* Allergy against insulin
* Mental incapacity
* Language barrier
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Principal Investigators

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Stepan Svacina, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Charles University Prague

Locations

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General University Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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eMPC_CUP1

Identifier Type: -

Identifier Source: org_study_id

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