NCT00996099

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below 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

September 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

11 months

First QC Date

October 15, 2009

Last Update Submit

October 15, 2009

Conditions

HyperglycemiaCardiac Surgery

Keywords

continuous glucose monitoringintensive insulin therapycritically illcardiac surgeryhyperglycemia of critically ill

Outcome Measures

Primary Outcomes (1)

  • Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)

    first 24 hours after cardiac surgery

Secondary Outcomes (1)

  • Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range

    first 24 hours after cardiac surgery

Study Arms (2)

CGM-eMPC

ACTIVE COMPARATOR
Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment

Control

OTHER
Other: Intensive insulin therapy using standard protocol

Interventions

Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatmentDEVICE

Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery

CGM-eMPC
Intensive insulin therapy using standard protocolOTHER

Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.

Control

Eligibility Criteria

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

You may qualify if:

  • elective cardiac surgery

You may not qualify if:

  • insulin allergy
  • mental incapacity
  • language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital

Prague, 128 00, Czechia

Location

MeSH Terms

Conditions

HyperglycemiaCritical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Haluzik, Prof, D.Sc.

    3rd Department of Medicine, General University Hospital, Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

CZ(1)