NCT00444171

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

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

September 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
Last Updated

March 7, 2007

Status Verified

March 1, 2007

First QC Date

March 5, 2007

Last Update Submit

March 5, 2007

Conditions

Cardiac Surgery PatientsBlood Glucose

Keywords

critically illinsulin resistanceintensive insulin therapycomputer algorithm

Outcome Measures

Primary Outcomes (2)

  • Mean blood glucose

  • percentage of time in target range

Secondary Outcomes (1)

  • Number of hypoglycaemic episodes

Interventions

insulin infusion rate controled by computer algorithmPROCEDURE
insulin infusion rate guided by in-house glucose management protocolPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cardiac surgery

You may not qualify if:

  • Allergy against insulin
  • Mental incapacity
  • Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital

Prague, 12808, Czechia

Location

MeSH Terms

Conditions

Critical IllnessInsulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stepan Svacina, MD, DSc

    Charles University 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

March 5, 2007

First Posted

March 7, 2007

Study Start

September 1, 2006

Study Completion

February 1, 2007

Last Updated

March 7, 2007

Record last verified: 2007-03

Locations

CZ(1)